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

This study has been completed.
Sponsor:
Information provided by:
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00224796
First received: September 21, 2005
Last updated: July 19, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Diabetic Foot
Device: V.A.C. ® System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.

Secondary Outcome Measures:
  • To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure
  • To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study
  • To determine the change in wound area over time
  • To determine the incidence of complications
  • To determine the effect of V.A.C. ® Therapy on the quality of life

Estimated Enrollment: 146
Study Start Date: May 2002
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224796

Sponsors and Collaborators
KCI USA, Inc.
Investigators
Principal Investigator: David Armstrong, DPM Rosalind Franklin University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00224796     History of Changes
Other Study ID Numbers: VAC2001-07
Study First Received: September 21, 2005
Last Updated: July 19, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by KCI USA, Inc.:
Wound closure
Foot salvage
Accelerated healing
Amputation Wounds of the Diabetic Foot

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on October 01, 2014