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

July 29, 2022 updated by: 3M

A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

146

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

  • Principal Investigator: David Armstrong, DPM, Rosalind Franklin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC2001-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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