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CompletedNCT00224796Updated Dec 2, 2024

Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot

A Phase 4 interventional study of V.A.C. ® System in Diabetic Foot, sponsored by KCI USA, Inc. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by KCI USA, Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Diabetic Foot

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Keywords

  • Wound closure
  • Foot salvage
  • Accelerated healing
  • Amputation Wounds of the Diabetic Foot
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In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 146 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

KCI USA, Inc is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants

Interventions

  • DeviceV.A.C. ® System
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What researchers measure

Primary outcomes

  1. To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.

Secondary outcomes

  1. To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure

  2. To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study

  3. To determine the change in wound area over time

  4. To determine the incidence of complications

  5. To determine the effect of V.A.C. ® Therapy on the quality of life

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. Erratum In: Clin Ther 1998 Mar-Apr;20(2):373. PubMed 9522113 ↗
  • 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. PubMed 9204802 ↗
  • 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. PubMed 2714164 ↗
  • 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. PubMed 9188970 ↗
  • 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. PubMed 10232203 ↗
  • 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. PubMed 9176007 ↗
  • Sibbald RG. Venous leg ulcers. Ostomy Wound Manage. 1998 Sep;44(9):52-64; quiz 65-6. PubMed 9866605 ↗
  • 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. PubMed 16291063 ↗
  • 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. PubMed 17425550 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00224796
Lead sponsor
KCI USA, Inc
First posted
Sep 23, 2005
Start date
May 2002
Completion
Oct 2005
Last update
Dec 2, 2024

Study contacts

David Armstrong, DPM
principal investigator · Rosalind Franklin University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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