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Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®)
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| ISRCTN | ISRCTN90301130 |
| ClinicalTrials.gov identifier | |
| Public title |
Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®)
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| Scientific title | Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®): A multicentre, randomised controlled trial |
| Acronym | DiaFoVAC |
| Serial number at source | DRKS00000059 |
| Study hypothesis |
This randomised controlled trial (RCT) comparing vacuum-assisted closure and conventional moist wound therapy (CMWT) for diabetic foot wounds was designed in order to:
1. Prove that VAC® therapy leads to complete healing of diabetic foot wounds more of-ten and earlier as compared to conventional moist wound therapy 2. Show that VAC® therapy is safe and effective also when provided in an ambulatory care setting 3. Generate more data on optimal patient selection and optimal combination of VAC® therapy with surgical closure |
| Ethics approval | The local ethics committee (Ethik-Kommission der Universität Witten/Herdecke) approved on the 8th of May 2009 (ref: 12/2009) |
| Study design | Multicentre randomised controlled clinical superiority trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Diabetic foot syndrome / chronic or amputational diabetic foot wound / wound treatment |
| Participants - inclusion criteria |
1. Evidence of diabetes mellitus type I, II or III as defined by the necessity for antidiabetic drugs for ≥ 12 months
2. All wounds corresponded to University of Texas grade 2 or 3 in depth 2.1. either a chronic wound which is planned to receive radical surgical debridement 2.2. or an amputational wound which results from a planned below-ankle amputation 3. Participant has given written informed consent |
| Participants - exclusion criteria |
1. Pregnancy
2. Age <18 years 3. Missing Compliance 4. Untreated or refractory phlegmona or untreated osteomyelitis of the wound 5. Exposed blood vessels in or around the wound that can't be protected or have a heightened risk for a bleeding with relevant circulation effects 6. Any revascularization procedure or amputation of the same extremity within the last 5 days 7. Indication for above-ankle amputation of the same extremity 8. Any extreme defective position of toes, foot or the whole extremity which could lead to ischemia of the wound area and impair wound healing 9. Evidence of inadequate perfusion 9.1. via MR angiography within the last 3 month or 9.2. sonographic confirmation of absence of peripheral pulse at A. tibialis posterior or A. dorsalis pedis) or 9.3. transcutaneous oxygen measurements of the dorsum of the foot ≤30 mmHg or 9.4. ankle brachial indices ≥0,7 and ≤1.2 and toe pressure at ≤30 mmHg 10. Renal insufficiency with need for dialysis 11. Anemia which is not caused infection 12. Long term use of oral (p.o.) steroids (> 30days) 13. Chronic anticoagulation except acetylsalicylate, clopidogrel (e.g. by vitamin K an-tagonists) at screening that can't be bridged to heparins during participation in the trial 14. Nerve lesions or active Charcot disease (Diabetic neuro-osteoarthropathy) of either lower extremity that will interfere with wound treatment 15. Malignancy in the wound or the periwound area or any other malignancy requiring immunosuppressant therapy or chemotherapy 16. Wounds resulting from burns, untreated cellulitis or collagen vascular disease 17. Presence of necrotic tissue that cannot be debrided 18. Concomitant severe skin disease that may impair wound healing 19. Connective tissue disease that might impair wound healing 20. Hematological disorders or condition that might impair wound healing 21. History of significant chronic anemia as evidenced by hemoglobin concentration of < 10 g/dl within 30 days of screening 22. Any kind of chronic venous insufficiency (CVI) or CVI that leads to varicose eczema, lo-cal inflammation and an increased risk of ulcers 23. Use of VAC® negative pressure wound therapy (NPWT) or any other suction device system on the study wound ≤ 8 days prior to screening 24. Previous treatment with hyperbaric oxygen therapy (HBO) or normothermic therapy in the past 8 days 25. Application of recombinant or autologous growth factors on the study wound ≤ 8 days prior to screening 26. Application of skin or dermal substitutes and dressings with living cells capable of producing growth factors (e.g. Oasis®, Apligraf®, Dermagraft™, or Integra®) on the study extremity < 15 days prior to screening 27. Allergy to any disposal component of the VAC® or MWT used materials 28. Simultaneous participation in other interventional trials interfering with one of the approaches in this trial 29. Previous participation in this trial |
| Anticipated start date | 01/06/2011 |
| Anticipated end date | 30/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 300 |
| Interventions |
Participants will be randomised to receive either:
1. Intervention: Vacuum-assisted-closure® based on negative pressure wound therapy (V.A.C® NPWT) 2. Control / Comparator: Conventional Moist Wound Therapy (CMWT) according to current available evidence based guidelines |
| Primary outcome measure(s) |
Time until complete (100%) wound closure, defined by the following criteria:
1. Full (100%) re-tepithelialization of the wound (i.e. no granulation tissue visible) 2. No drainage 3. No need for wound dressing |
| Secondary outcome measure(s) |
1. Clinical endpoints
1.1. Wound size (area of wound opening, maximal length and width) 1.2. Composition of wound tissue (percentage of epithelia layer, granulation tissue and fibrin) 1.3. Pain in wound surrounding (until wound closure and at 12 months) 1.4. Incidence and time of wound bed preparation 1.5. Secondary resections and amputations 1.6. Recurrence of wound or ulcer at same site 1.7. Complication rates (local and systemic) 1.8. Total complication rate 1.9. Mortality of any cause (within 12 month) 2. Health economic endpoints 2.1. Number of dressing changes 2.2. Length of treatment 2.3. Length of hospital stay 2.4. Time until orthopedic footwear supply possible 2.5. Time until return to work 2.6. Quality-of-life during treatment 2.7. Quality of life after Healing (at 6 and 12 months) 2.8. Patient satisfaction 2.9. Costs (in and out hospital) |
| Sources of funding | Kinetic Concepts, Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Ms Dörthe Seidel |
| Address |
Institut für Forschung in der Operativen Medizin
Private Universität Witten / Herdecke gGmbH Ostmerheimerstraße 200 Haus 38 |
| City/town | Köln |
| Zip/Postcode | 51109 |
| Country | Germany |
| Tel | +49 (0) 221 9895719 |
| Fax | +49 (0) 221 9895730 |
| doerthe.seidel@uni-wh.de | |
| Sponsor | Private University of Witten/Herdecke gGmbH (Germany) |
| Address |
Medical Faculty
Alfred-Herrhausen-Str. 50 |
| City/town | Witten |
| Zip/Postcode | 58448 |
| Country | Germany |
| sekretariat-neugebauer@uni-wh.de | |
| Sponsor website: | http://www.uni-wh.de |
| Date applied | 13/07/2010 |
| Last edited | 29/07/2010 |
| Date ISRCTN assigned | 29/07/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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