Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®)

ISRCTN ISRCTN90301130
DOI https://doi.org/10.1186/ISRCTN90301130
Secondary identifying numbers DRKS00000059
Submission date
13/07/2010
Registration date
29/07/2010
Last edited
29/07/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Dörthe Seidel
Scientific

Institut für Forschung in der Operativen Medizin
Private Universität Witten / Herdecke gGmbH
Ostmerheimerstraße 200 Haus 38
Köln
51109
Germany

+49 (0) 221 9895719
doerthe.seidel@uni-wh.de

Study information

Study designMulticentre randomised controlled clinical superiority trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleTreatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®): A multicentre, randomised controlled trial
Study acronymDiaFoVAC
Study objectivesThis 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(s)The local ethics committee (Ethik-Kommission der Universität Witten/Herdecke) approved on the 8th of May 2009 (ref: 12/2009)
Health condition(s) or problem(s) studiedDiabetic foot syndrome / chronic or amputational diabetic foot wound / wound treatment
InterventionParticipants 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
Intervention typeOther
Primary outcome measureTime 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 measures1. 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)
Overall study start date01/06/2011
Completion date30/09/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2011
Date of final enrolment30/09/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

Institut für Forschung in der Operativen Medizin
Köln
51109
Germany

Sponsor information

Private University of Witten/Herdecke gGmbH (Germany)
University/education

Medical Faculty
Alfred-Herrhausen-Str. 50
Witten
58448
Germany

sekretariat-neugebauer@uni-wh.de
http://www.uni-wh.de
ROR logo https://ror.org/00yq55g44

Funders

Funder type

Industry

Kinetic Concepts, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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