Clinical trial NCT00224796: Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
Official title: A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot
Keywords: Wound closure
Foot salvage
Accelerated healing
Amputation Wounds of the Diabetic Foot
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.


Eligibility criteria: Inclusion Criteria:

1. Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot
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:

1. Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
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.

Primary outcomes:
measure: To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.
Secondary outcomes:
measure: To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure
measure: To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study
measure: To determine the change in wound area over time
measure: To determine the incidence of complications
measure: To determine the effect of V.A.C. ® Therapy on the quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Rosalind Franklin University
name: David Armstrong, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Sibbald RG. Venous leg ulcers. Ostomy Wound Manage. 1998 Sep;44(9):52-64; quiz 65-6.
citation: 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.
citation: 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.