Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
NCT ID: NCT00224796
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
146 participants
INTERVENTIONAL
2002-05-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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V.A.C. ® System
Eligibility Criteria
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Inclusion Criteria
2. Evidence of adequate perfusion by one of the following on the affected extremity, (within the past 60 days):
* Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or
* Ankle brachial index (ABIs) with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or
* Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
3. Age ≥ 18 years of age
4. HbA1c ≤ 12% (collected within the last 90 days.)
5. Evidence of adequate nutrition by one of the following:
* Lab results reflecting Pre-Albumin ≥16 mg/dl and Albumin level is ≥3 g/dl (during the seven days prior to the study period), or
* A nutritional consult will be done and with appropriate supplementation started. Proper documentation on (case report forms)CRFs is needed.
Exclusion Criteria
2. Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency
3. Untreated infection or cellulitis at site of target wound
4. Presence of untreated osteomyelitis
5. Collagen vascular disease
6. Malignancy in the wound
7. Presence of necrotic tissue in the wound
8. Uncontrolled hyperglycemia
9. Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
10. Prior V.A.C.® therapy within 30 days.
11. Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (HBO) therapy within 30 days.
12. Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
13. Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
18 Years
ALL
No
Sponsors
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KCI USA, Inc
INDUSTRY
Principal Investigators
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David Armstrong, DPM
Role: PRINCIPAL_INVESTIGATOR
Rosalind Franklin University
References
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Holzer SE, Camerota A, Martens L, Cuerdon T, Crystal-Peters J, Zagari M. Costs and duration of care for lower extremity ulcers in patients with diabetes. Clin Ther. 1998 Jan-Feb;20(1):169-81. doi: 10.1016/s0149-2918(98)80044-1.
Glover JL, Weingarten MS, Buchbinder DS, Poucher RL, Deitrick GA 3rd, Fylling CP. A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care. 1997 Jan-Feb;10(1):33-8.
Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower-extremity amputation in people with diabetes. Epidemiology and prevention. Diabetes Care. 1989 Jan;12(1):24-31. doi: 10.2337/diacare.12.1.24.
Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
Banwell PE. Topical negative pressure therapy in wound care. J Wound Care. 1999 Feb;8(2):79-84. doi: 10.12968/jowc.1999.8.2.25844. No abstract available.
Mullner T, Mrkonjic L, Kwasny O, Vecsei V. The use of negative pressure to promote the healing of tissue defects: a clinical trial using the vacuum sealing technique. Br J Plast Surg. 1997 Apr;50(3):194-9. doi: 10.1016/s0007-1226(97)91369-2.
Sibbald RG. Venous leg ulcers. Ostomy Wound Manage. 1998 Sep;44(9):52-64; quiz 65-6.
Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
Other Identifiers
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VAC2001-07
Identifier Type: -
Identifier Source: org_study_id