Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00432965
First received: February 6, 2007
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.

The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. 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 ulcer closure or facilitation of surgical closure, reduction of ulcer surface area over time, reduction in complications, the quality of life and the average total cost of care.


Condition Intervention Phase
Diabetic Foot Ulcers
Device: Moist Wound Therapy
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: KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"

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 ulcer closure. [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42, Day 56, Day 84 and Day 112, (Also done at 1st & 2nd follow up visits if wound closure occurs) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The accelerated ulcer closure or facilitation of surgical closure. [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42, Day 56, Day 84 and Day 112, (Also done at 1st & 2nd follow up visits if wound closure occurs) ] [ Designated as safety issue: No ]

Enrollment: 338
Study Start Date: May 2002
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAC Therapy
Treatment of Diabetic Foot Ulcers with VAC Therapy
Device: Moist Wound Therapy
Moist Wound Therapy (Standard of Care)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
  • DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
  • 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 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.
  • Age ≥ 18 years of age
  • HbA1c ≤ 12% (collected within the last 90 days.)
  • 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 CRFs is needed.

Exclusion Criteria:

  • Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
  • Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
  • Untreated infection or cellulites at site of target ulcer
  • Presence of untreated osteomyelitis
  • Collagen vascular disease
  • Malignancy in the ulcer
  • Presence of necrotic tissue
  • Uncontrolled hyperglycemia
  • Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
  • Open amputations
  • Prior V.A.C. therapy within 30 days.
  • Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days.
  • Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
  • Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
  • Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study
  • Pregnant or nursing mothers.
  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: NCT00432965

  Show 25 Study Locations
Sponsors and Collaborators
KCI USA, Inc.
Investigators
Principal Investigator: Peter Blume, DPM North American Center for Limb Preservation
  More Information

No publications provided

Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT00432965     History of Changes
Other Study ID Numbers: VAC2001-08
Study First Received: February 6, 2007
Last Updated: September 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by KCI USA, Inc.:
Wound closure
Accelerated healing

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

ClinicalTrials.gov processed this record on August 28, 2014