Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/07/2010
Date assigned
29/07/2010
Last edited
29/07/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Dörthe Seidel

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS00000059

Study information

Scientific title

Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure (VAC®): A multicentre, randomised controlled trial

Acronym

DiaFoVAC

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Diabetic foot syndrome / chronic or amputational diabetic foot wound / wound treatment

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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)

Overall trial start date

01/06/2011

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/06/2011

Recruitment end date

30/09/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Institut für Forschung in der Operativen Medizin
Köln
51109
Germany

Sponsor information

Organisation

Private University of Witten/Herdecke gGmbH (Germany)

Sponsor details

Medical Faculty
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
sekretariat-neugebauer@uni-wh.de

Sponsor type

University/education

Website

http://www.uni-wh.de

Funders

Funder type

Industry

Funder name

Kinetic Concepts, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes