A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

Organogenesis1 site in 1 country314 target enrollmentDecember 1998

ConditionsDiabetic Foot Ulcer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Organogenesis
Enrollment: 314
Locations: 1
Primary Endpoint: Complete wound closure
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.

Registry

clinicaltrials.gov

Start Date

December 1998

End Date

March 2000

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organogenesis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is 18 years of age or older.
•Patient has type I or II diabetes.
•Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care.
•Foot ulcer is on the plantar surface of the forefoot or heel.
•Ulcer size is \>/=1.0 cm2 at Day 0 (day of randomization).
•Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
•Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue.
•Patient's Ankle-Arm Index by Doppler is \>/=0.
•Patient has adequate circulation to the foot as evidenced by a palpable pulse.
•Female patients of child bearing potential must not be pregnant and must use accepted means of birth control.

Exclusion Criteria

•There is clinical evidence of gangrene on any part of the affected foot.
•The study ulcer is over a Charcot deformity.
•The study ulcer is due to a nondiabetic etiology.
•The ulcer has tunnels or sinus tracts that cannot be completely debrided.
•The ulcer is \>20 cm2 (longest dimension cannot be greater than 5 cm).
•The ulcer has increased or decreased in size by 50% or more during the screening period.
•Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study.
•Presence of a malignant disease not in remission for 5 years or more.
•Evidence of severe malnutrition, based on a serum albumin level \<2.
•Presence of patient having known alcohol or drug abuse.