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Status:

COMPLETED

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

Lead Sponsor:

KCI USA, Inc

Conditions:

Diabetic Foot Ulcers

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

335 Patients enrolled

Trial Details

Trial ID

NCT00432965

Start Date

May 1 2002

End Date

March 1 2008

Last Update

October 16 2024

Active Locations (25)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 7 (25 locations)

1

Maricopa Medical Center

Phoenix, Arizona, United States, 85008

2

Hope Research Institute

Phoenix, Arizona, United States, 85015

3

Tucson Vascular Surgery, PLLC

Tucson, Arizona, United States, 85704

4

Southern Arizona VA Medical Center, Dept. Surgery

Tucson, Arizona, United States, 85723