Archived Policies - DME


Noncontact Wound Therapy

Number:DME101.044

Effective Date:07-01-2015

End Date:06-30-2016

Coverage:

Ultrasound wound (US) therapy is considered experimental, investigational and/or unproven.

Use of noncontact normothermic wound therapy, either as a primary intervention or as an adjunct to other wound therapies, is considered experimental, investigational and/or unproven.

Description:

Ultrasound (US) Wound Therapy

Low frequency ultrasound (US) in the kilohertz range may improve wound healing. Several noncontact US devices have received regulatory approval for wound treatment.

US is defined as a mechanical vibration above the upper threshold of human hearing (>20 kilohertz [kHz]). US in the megahertz range (1-3 megahertz [MHz]) have been used for the treatment of musculoskeletal disorders, primarily by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, and collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the kilohertz range have also been examined. Low-frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.

The mechanical energy from US is typically transmitted to tissue through a coupling gel. Several high- intensity US devices with contact probes are currently available for wound débridement. Recently, low- intensity US devices have been developed that do not require use of a coupling gel or other direct contact. The MIST Therapy™ System (Celleration, Eden Prairie, MN) delivers a saline mist to the wound with low-frequency US (40 KHz). A second device, the Qoustic Wound Therapy System™ (Arobella Medical, Minnetonka, MN), also uses sterile saline to deliver US energy (35 KHz) for wound debridement and irrigation.

In 2005, the Celleration MIST Therapy device received marketing clearance through the United States (U.S.) Federal Drug Administration (FDA) 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” Several wound drainage and wound vacuum systems were listed as predicate devices. In 2004, the FDA had reclassified these devices from class III to class II at the request of Celleration.

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical) received marketing clearance, listing the Celleration MIST system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system uses a combination of irrigation and US with a contact probe to debride and cleanse wounds. The indications are similar to that of the MIST system, listed as: “selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.” This device is now known as the Qoustic Wound Therapy System™. Several other devices have been approved as being substantially equivalent to the earlier devices. FDA product code: NRB

Normothermic Wound Therapy

An optimal environment for wound healing is thought to include a moist normothermic environment that functions in part to enhance the subcutaneous oxygen tension and to increase the blood flow to the wound. Warm-up active wound therapy is a device approved for marketing by the U.S. FDA that attempts to create this environment. The device includes a noncontact bandage and a warming unit designed to maintain 100% relative humidity and to produce normothermia in the wound and surrounding tissues. The bandage is composed of a sterile foam collar that adheres to the periwound skin and a sterile, transparent film that covers the top of the wound but does not touch it. An infrared warming card is inserted into a pocket in the film covering. Treatments are typically administered 3 times per day in 1-hour sessions.

Rationale:

Ultrasound (US) Wound Therapy

The literature review focused on studies, preferably randomized, evaluating whether the addition of noncontact US improves wound healing in comparison with standard treatment alone.

Two systematic reviews were published in 2011. An industry-sponsored review by Driver et al. considered both controlled and uncontrolled studies on noncontact low-frequency US therapy for treating chronic wounds. (1) To be eligible for inclusion, studies had to have at least 4 weeks of follow-up. Ten studies were initially identified and 2 were excluded, 1 because data were not in a form suitable for pooling and the other because follow-up time was too short. Of the remaining 8 studies, 1 was a randomized controlled trial (RCT) and the remainder was observational studies (5 retrospective analyses and 2 prospective studies). A pooled analysis of findings from 7 studies (total N=429) found that a mean of 32.7% (95% confidence interval [CI], 23.3% to 42.1%) of patients had healed wounds by a mean of 6 weeks. A pooled analysis of 4 studies (total N=188) found a mean of 85.2% (95% CI, 64.7% to 97.6%) reduction in wound area by final follow-up. The major limitation of this meta-analysis was that there were no pooled comparisons of noncontact US therapy to optimal wound care alone, or to an alternative intervention. Thus conclusions cannot be drawn about the incremental benefit of noncontact US treatment over optimal wound care alone.

The second systematic review only included RCTs; studies used noncontact or contact US for treating chronic wounds. (2) Five RCTs were identified on noncontact US, 1 of which was unpublished. The authors conducted 1 pooled analysis of study findings. This meta-analysis of 2 RCTs found a significantly smaller proportion of non-healed wounds at 3 months in the noncontact US group compared with the control group (risk ratio, 0.74; 95% CI, 0.58 to 0.95). The ability to draw conclusions from this meta-analysis is limited because only 2 RCTs were included and 1 of these used noncontact US delivered during foot bathing (i.e., did not use a modern device). The other RCT, by Ennis et al. had potential methodologic limitations.

Details of the 2 industry-sponsored RCTs that have assessed the incremental benefit of MIST therapy on wound healing are as follows:

In 2005, Ennis et al. published findings of a double-blind multicenter RCT that used MIST therapy for recalcitrant diabetic foot ulcers. (3) Most of the 133 patients (85%) were enrolled and treated at 17 different wound clinics/private practice centers. An additional 15% of patients were enrolled at 6 university medical clinics. Patients with recalcitrant foot ulcers were treated with active or sham saline mist therapy 3 times per week, with debridement as needed and a weekly evaluation by an independent investigator. Twenty- four patients were lost to follow-up, and data from 54 patients were excluded from analysis due to protocol violations (5 centers were found to have inverted the treatment distances for the active and sham devices), leaving 55 patients (41%) for the per-protocol analysis. The investigators reported significant improvement in the active treatment group (11 of 27 patients, 41%) compared with the control group (4/28 patients, 14%) in the proportion of wounds healed (defined as complete epithelialization without drainage). However, intention to treat analysis showed no difference in wound healing (26% vs 22%, respectively) between the active (n=70) and control (n= 63) groups. In addition to the 59% loss to follow-up, there was a difference in the ulcer area at baseline (1.7 vs 4.4 cm2, respectively) and chronicity of wounds (35 vs 67 weeks, respectively) that favored MIST therapy in the per protocol groups. Due to the serious limitations of this study, these results are considered inconclusive.

In 2007, Kavros et al. published an open-label (non-blinded) RCT comparing 12 weeks of MIST therapy plus standard care (SC) to SC alone in 70 patients with nonhealing (2 months) foot, ankle, or leg. (4) To participate, patients need to have documented ischemia (transcutaneous oximetry of <40 mm Hg) and agree to 3 times per week visits for therapy. The study found that a greater proportion of patients in the MIST therapy group (22/35 [63%]) achieved wound healing (defined as a reduction of wound area >50%) in comparison with standard of care alone (10/35 patients [29%]). The authors did not control for potential nonspecific effects of the additional treatment sessions for patients in the noncontact US group, e.g., by including a sham treatment group. In addition, although the study reported on the importance of baseline transcutaneous partial pressure of oxygen (TcPO2) on wound healing, patients with low (1-20 mm Hg) and high (21-40 mm Hg) TcPO2 levels did not appear to be equally distributed between the groups.

Since publication of the 2011 systematic reviews, 1 additional RCT was published that evaluated the incremental benefit of noncontact US on wound healing. The study, by Olyaie et al., was non-blinded and was conducted in Iran. (5) Sponsorship of the study was not discussed. Ninety patients with venous leg ulcers were randomized to 1 of 3 groups (30 patients per group): SC only; SC plus high-frequency US; or noncontact US using MIST therapy. Patients in the 2 US groups received treatments 3 times per week for 3 months or until healing occurred. After 4 months, mean (SD) ulcer size was 3.23 cm2 (2.39) in the high-frequency US group, 2.72 cm2 (2.16) in the noncontact US group, and 4.28 cm2 (2.80) in the SC group (p<0.04). Patients were followed for a mean of 7.5 months. The mean (SD) time to complete healing (in months) was 6.86 (2.04) in the high-frequency US group, 6.65 (1.59) in the noncontact US group, and 8.50 (2.17) in the SC group. The difference in time to healing among the 3 groups was statistically significant (p<0.001). The authors did not report paired comparisons between the SC and noncontact US groups. The main limitation of this trial is that it was not blinded—this could have led to differential treatment of patients in the 3 groups as they received SC and could have biased outcome assessment. Also, as evidenced by the complete healing of ulcers in all patients in the SC group, it is unlikely that patients had received optimal wound care before enrolling in the study.

In 2012, Honaker et al. (6) evaluated the effects of non-contact low frequency US on the healing of suspected deep tissue injury (SDTI). Adult participants ranged in age from 28 to 93 years old, with multiple diagnoses including anemia, diabetes mellitus and hypertension were included. Data was examined retrospectively on 85 patients (intervention group = 43 and nonintervention group = 42) with 127 SDTI (intervention group = 64 and nonintervention group = 63). Participants in both groups received standard of care for treating pressure ulcers. A severity score was used to assess SDTI severity before treatment and healing/progression after treatment. This scale measures surface area, wound color/tissue assessment, and skin integrity with potential scores of 3 to 18 (higher scores indicate greater severity). A significant difference in changes in wound severity was found (t = 5•67, P < 0.000). Difference in mean change scores was 2•52 on the 3-18 severity scale. The decrease in wound severity for the intervention group was 1•45. Severity in the nonintervention group increased by 1•06. This exploratory study of the effect of the non-contact low-frequency ultrasound provides initial findings that support its use with SDTI.

In 2014, Ebrahim et al. (7) performed a network meta-analysis to indirectly compare low intensity pulsed ultrasonography (LIPUS) with electrical stimulation (ESTIM) for fracture healing. The investigators searched the reference lists of recent reviews evaluating LIPUS and ESTIM that included studies published up to 2011 from 4 electronic databases. They updated the searches of all electronic databases up to April 2012. Eligible trials were those that included patients with a fresh fracture or an existing delayed union or nonunion who were randomized to LIPUS or ESTIM as well as a control group. Two pairs of reviewers, independently and in duplicate, screened titles and abstracts, reviewed the full text of potentially eligible articles, extracted data and assessed study quality. These researchers used standard and network meta-analytic techniques to synthesize the data. Of the 27 eligible trials, 15 provided data for the analyses. In patients with a fresh fracture, there was a suggested benefit of LIPUS at 6 months (RR 1.17, 95 % CI: 0.97 to 1.41). In patients with an existing nonunion or delayed union, ESTIM had a suggested benefit over SC on union rates at 3 months (RR 2.05, 95 % CI: 0.99 to 4.24). The researchers found very low-quality evidence suggesting a potential benefit of LIPUS versus ESTIM in improving union rates at 6 months (RR 0.76, 95 % CI: 0.58 to 1.01) in fresh fracture populations. The authors concluded that to support these findings, direct comparative trials with safeguards against bias assessing outcomes important to patients, such as functional recovery, are needed.

In 2015, Gibbons et al. (8) completed a prospective RCT comparing the effects of non-contact, low frequency ultrasound (NLFU) to SC in healing venous leg ulcers. The study was conducted to compare the percentage of wound size reduction, proportions healed, pain, and quality-of-life (QOL) outcomes in patients randomized to SC alone or SC and 40 kHz NLFU treatments 3 times per week for 4 weeks. One hundred, twelve (112) eligible participants with documented venous stasis, a venous leg ulcer (VLU) >30 days' duration, measuring 4 cm2 to 50 cm2, and demonstrated arterial flow were enrolled. Of these, 81 reduced <30% in size during the 2-week run-in study phase and were randomized (SC, n = 40; NLFU+SC, n = 41). Median age of participants was 59 years; 83% had multiple complex comorbidities. Index ulcers were 56% recurrent; with a median duration of 10.3 months (range 1 month to 204.5 months) and median ulcer area of 11.0 cm2 (range 3.7 cm2-41.3 cm2). All participants received protocol-defined SC compression (30-40 mm Hg), dressings to promote a moist wound environment, and sharp debridement at the bedside for a minimum of 1 time per week. Ulcer measurements were obtained weekly using digital planimetry. Pain and QOL scores were assessed at baseline and after 4 weeks of treatment using the Visual Analog Scale and the Short Form-36 Health Survey. After 4 weeks of treatment, average wound size reduction was 61.6% ± 28.9 in the NLFU+SC compared to 45% ± 32.5 in the SC group (P = 0.02). Reductions in median (65.7% versus 44.4%, P = 0.02) and absolute wound area (9.0 cm2 versus 4.1 cm2, P = 0.003) as well as pain scores (from 3.0 to 0.6 versus 3.0 to 2.4, P = 0.01) were also significant. NLFU therapy with guideline-defined standard VLU care should be considered for healing VLUs not responding to SC alone. The results of this study warrant further research on barriers to healing and the changes occurring in the tissue of the wound to explore theories that the microenvironment impacts wounds that do not heal despite provision of guideline defined care.

In 2015, White et al. (9) completed an open label, assessor-blinded, single-site, RCT which assessed NLFU and the United Kingdom (U.K.) standard of care [SOC: (NLFU+SOC)] 3 times a week, with SOC alone at least 1time per week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomized patients completed treatment (17 NLFU+SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU+SOC patients showed a -47% (SD: 38%) change in wound area; SOC, -39% (38%) change; and difference, -74% [95% confidence intervals (CIs) -334-186; P = 0565]. The median number of infections per patient was 2 in both arms of the study and change in quality of life (QOL) scores was not significant (P = 0490). NLFU+SOC patients reported a substantial mean (SD) reduction in pain score of -144 (149) points, SOC patients' pain scores reduced by -53 (148); the difference was -91 (P = 0078). Results demonstrated the importance of high quality wound care. Outcome measures favored NLFU+SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow-up may reveal NLFU related improvements that were not identified in this study. The authors stated it is not possible to conclude that NLFU therapy 3 times a week with SOC accelerates healing in chronic venous leg ulcers compared with SOC alone. This study was funded by the device manufacturer.

Ongoing and Unpublished Clinical Trials

MIST Ultrasound Therapy Compared to UK SC for the Treatment of Non-healing Venous Leg Ulcers (NCT01671748) (10): This single-blind RCT is comparing MIST US therapy with SC in the U.K. as treatment of nonhealing venous leg ulcers. The primary outcome is change in wound area. The investigators expect to enroll 40 patients, and the expected date of study completion is November 2013. As of May 19, 2015, no study results are posted and the study is ongoing.

Effects of Non-Contact Low Frequency US in Healing Venous Leg Ulcers (NCT01549860) (11): This single-blind RCT is underway at multiple sites in the U.S., is comparing MIST US therapy plus SOC with SOC alone for the treatment of nonhealing lower extremity venous ulcers The primary outcome measure is the wound reduction area after 4 weeks. Estimated enrollment is 156 patients and the expected date of study completion is December 2014. As of May 19, 2015, no study results are posted and the study is ongoing.

Practice Guidelines and Position Statements

In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on the care of pressure ulcers. (12) Noncontact US therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing. The strength of this evidence was low (level C), indicating there is limited evidence for this technology.

In 2010, the AAWC updated their guideline to state that low-frequency US treatment requires additional evidence before it can be considered an appropriate treatment. (13)

The National Institute for Health and Clinical Excellence (NICE 2011 ) states the SOC for “hard to heal” wounds normally involves the use of advanced wound dressings, which includes alginate, capillary action, charcoal, foam, honey, hydrocolloid, hydrocolloid fibrous, hydrogel, iodine, low or non-adherent wound contact layer, silicone and silver dressings. For venous ulcers, compression bandaging is the mainstay of treatment, provided ischaemia is not present. Standard practice for chronic wounds also includes wound debridement and systemic antibiotic therapy for patients with wounds showing clinical signs of infection. NICE's report on MIST therapynoted that the committee considered that the MIST Therapy system showed promise in the treatment of chronic wounds but the low-quality of evidence and consequent uncertainty about its relative effectiveness in healing wounds compared with SC alone meant that the case for routine adoption in the guideline could not be supported. (14)

Summary of Evidence

The available published evidence does not permit conclusions concerning the effect of noncontact US on health outcomes compared with standard wound treatment. Several RCTs have evaluated the incremental benefit of commercially available noncontact US devices on wound healing. Well designed, blinded studies that have adequate numbers of patients and include all relevant outcomes are needed to further evaluate the efficacy of this treatment. Therefore, noncontact US treatment for wounds is considered experimental, investigational and/or unproven.

Normothermic Wound Therapy

Standard components of wound care include sharp debridement of devitalized tissue, infection control, non-weight bearing, and treatment of underlying co-morbidities, such as adequate nutrition or glycemic control in diabetics. Therefore, validation of any adjunct to standard wound management requires a RCT to isolate the contribution of the intervention compared to underlying wound management. A literature review identified one small, randomized crossover trial of warm-up active wound therapy involving 13 patients who were followed up for 2 weeks. (16) Compared to the control group, more patients in the treatment group improved (62.5% vs. 37.5%). However, the term “improvement” was not fully defined, and no statistical analysis was provided. Santilli and colleagues reported a two-week trial of warm up active wound therapy in which 17 patients with 31 wounds served as their own control. (17) Almost half of these patients, all refractory to prior therapy, reported complete healing within 12 weeks after treatment. While studies of wound healing therapies frequently use patients as their own control, this trial design cannot isolate the contribution of the intervention. It is possible that the wound healing effect may be in part due to increased attentiveness to underlying wound care rather than to the warm up active wound therapy itself. Finally, Cherry and Wilson reported on a case series of 5 patients who received a two-week trial of warm up active wound therapy. (18) Although 4 of the 5 patients reported complete healing at 6-14 weeks after treatment, a case series does not permit isolation of the contribution of the warm up therapy. In addition, both in this trial and in the previous trial reviewed (17), it should be noted that wound healing occurred several weeks after discontinuation of the warm up therapy, further confounding any evaluation of the therapy.

In January 2002, the Centers for Medicare and Medicaid Services (CMS) published a review of the available literature of noncontact normothermic wound therapy, specifically literature focusing on the warm up active wound therapy device. (19) CMS identified 8 articles that met their selection criteria, including 5 randomized studies (two of which were not yet published) and 3 case series. Data were separately analyzed for different types of wounds, i.e., pressure ulcers, venous stasis ulcers, diabetic/neuropathic ulcers, non-healing surgical incisions, and other types of chronic wounds. The CMS review identified methodologic flaws in all the trials in ensuring standard wound care in all patients, reporting outcomes, or reporting statistical or clinical significance of outcomes. The CMS assessment offered the following conclusion:

"In summary, the medical literature does not support a finding that noncontact normothermic wound therapy (NNWT) heals any wound type better than conventional treatment. While the submitted studies purport better healing, due to serious methodologic weaknesses, inadequate controls, and a variety of biases, the improved outcomes could also easily disappear in a properly controlled randomized trial. Furthermore, there is no reason why such a trial could not be readily performed. A trial that would best answer our coverage concerns would be one in which there was randomization to three arms: 1) experimental arm which would receive NNWT; 2) experimental arm which would receive NNWT, but with the heating element turned off; and 3) control arm, which would only receive conventional therapy. Conventional therapy should be standardized across all three arms as applicable."

Since the CMS decision, results from four small studies (ranging in size from 16–36 patients) were published that found increased wound healing time with use of noncontact normothermic wound therapy. (20-23) However, none of these studies was a controlled randomized, three-arm trial to isolate the effect of the intervention and address the trial design issues noted. (20, 22, 23) In addition, stratification of wound size, duration, and location are also necessary in trial design.

Alvarez et al. conducted a small (49 patients) open-label randomized trial with standard therapy controls. (24) The study found an improvement in wound healing with NNWT; at 12 weeks, 18% of NNWT wounds had complete healing compared to 9% in the control group. However, as the authors noted, the three hours per day of off-loading (application for one hour three times per day), may have improved patient compliance to off-loading instructions. A study in a larger patient population with the appropriate control groups, as described, is needed.

Practice Guidelines and Position Statements

The 2010 Association for the Advancement of Wound Care (AAWC) guideline on treatment of venous ulcers does not include normothermic wound therapy as a potential treatment modality. (13)

Summary of Evidence

In summary, improved health outcomes have not been demonstrated with the use of a noncontact radiant heat bandage. Additional studies are needed to further evaluate the safety and efficacy of this treatment modality.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97610, [Deleted 1/2014:0183T]

HCPCS Codes

E0231, E0232, A6000

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position on Noncontact Normothermic Wound Therapy.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Ultrasound (US) Wound Therapy

1.      Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis. Wound Rep Reg. 2011; 19(4):475-480.  

2.      Voigt J, Wendelken M, Driver V, et al. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds. December 2011; 10(4):190-199. PMID 22184750.

3.      Ennis WJ, Foremann P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005; 51(8):24-39.  

4.      Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo Clinic experience, 2004-2006. Adv Skin Wound Care. 2007; 20(4):221-226.  

5.      Olyaie M, Rad FS, Elahifar MA, et al. High-frequency and Noncontact Low-frequency Ultrasound Therapy for Venous Leg Ulcer Treatment: A Randomized, Controlled Study. Ostomy Wound Manage. August 2013; 59(8):14-20. PMID 23934374.

6.     Honaker Jeremy et al. Effects of non-contact low frequency ultrasound on healing of suspected deep tissue injury: a retrospective analysis. Int Wound Journal 2012.

7.     Ebrahim S, Mollon B, Bance S, et al. Low-intensity pulsed ultrasonography versus electrical stimulation for fracture healing: A systematic review and network meta-analysis. Can J Surg. 2014; 57(3):E105-E118.

8.     Gibbons Gary M.D. et al. A prospective, randomized, controlled trial comparing the effects of noncontact low frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Management 2015; 61(1):16-29.

9.     White Judith et al. Non-contact low frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single centre, assessor-blinded, randomized control trial. International Wound Journal 2015.

10.   Sponsored by Cardiff and Vale University Health Board in collaboration with Celleration. MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers (NCT01671748). <www.clinicaltrials.gov>. (Accessed 2015 May 19).

11.   Sponsored by Celleration Inc. Effects of Non-Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (NCT01549860). Available at <www.clinicaltrials.gov>. (Accessed 2015 May 19).

12.   Association for the Advancement of Wound Care (AAWC). Pressure Ulcer Guideline. Available at < www.guideline.gov>. (Accessed 2015 May 19).

13.   Association for the Advancement of Wound Care (AAWC) (2005- revised 2010). Venous Ulcer Guideline. <www.guideline.gov>. (Accessed 2015 May 19).

14.  National institute for health and clinical excellence (NICE). The Mist therapy system for the promotion of wound healing. Medical Technology guidance 5 (2011 July). Available at <www.nice.org.uk> (Accessed 2015 April 14).

15.  Non-Contact Ultrasound Treatment for Wounds. Chicago, Illinois: Blue Cross Blue Shield Association medical Policy reference Manual (2014 November) Medicine; 2.01.79.

Normothermic Wound Therapy

16.  Robinson C, Santilli SM. Warm-Up Active Wound Therapy: a novel approach to the management of chronic venous stasis ulcers. J Vasc Nurs 1998; 16(2):38-42.

17.  Santilli SM, Valusek PA, Robinson C. Use of a noncontact radiant heat bandage for the treatment of chronic venous stasis ulcers. Adv Wound Care 1999; 12(2):89-93.

18.  Cherry GW, Wilson J. The treatment of ambulatory venous ulcer patients with warming therapy. Ostomy Wound Manage 1999; 45(9):65-70.

19.   CMS—National Coverage Determination for Noncontact Normothermic Wound Therapy (NNWT) (270.2). (2002 January 14). Centers for Medicare and Medicaid Services. Available at <www.cms.gov>. (Accessed 2015 May 19).

20.  McCulloch J, Knight CA. Noncontact normothermic wound therapy and offloading in the treatment of neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage 2002; 48(3):38-44.

21.  Kloth LC, Berman JE, Nett M et al. A randomized controlled clinical trial to evaluate the effects of noncontact normothermic wound therapy on chronic full-thickness pressure ulcers. Adv Skin Wound Care 2002; 15(6):270-6.

22.  Alvarez OM, Rogers RS, Booker JG et al. Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: an interim analysis of 20 patients. J Foot Ankle Surgery 2003; 42(1):30-5.

23.  Karr JC. External thermoregulation of wounds associated with lower-extremity osteomyelitis. A pilot study. J Am Podiatr Med Assoc 2003; 93(1):18-22.

24.  Alvarez O, Patel M, Rogers R et al. Effect of non-contact normothermic wound therapy on the healing of diabetic neuropathic foot ulcers. J Tissue Viability 2006; 16(1):8-11.

25.  Noncontact Radiant Heat Bandage for the Treatment of Wounds.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 July-Archived) Medicine: 2.01.41.

 

Policy History:

Date Reason
7/1/2015 Policy updated with literature review. Coverage unchanged.
11/1/2014 Document updated with literature review. Coverage unchanged.
4/15/2012 Document updated with literature review. Coverage unchanged.
4/1/2010 Document updated with literature review. Coverage unchanged.
1/1/2008 Document updated with literature review. The following change was made: Noncontact, low frequency ultrasound wound therapy is considered experimental, investigational and unproven.
10/1/2006 Document updated with literature review
7/1/2004 New medical document.

Archived Document(s):

Title:Effective Date:End Date:
Ultrasound Wound Therapy07-01-201804-14-2019
Ultrasound Wound Therapy06-15-201706-30-2018
Ultrasound Wound Therapy07-01-201606-14-2017
Noncontact Wound Therapy07-01-201506-30-2016
Noncontact Wound Therapy11-01-201406-30-2015
Noncontact Wound Therapy04-15-201210-31-2014
Noncontact Wound Therapy04-01-201004-14-2012
Noncontact Wound Therapy01-01-200803-31-2010
Noncontact Normothermic Wound Therapy10-01-200612-31-2007
Noncontact Normothermic Wound Therapy07-01-200409-30-2006
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