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

Organogenesis1 site in 1 country281 target enrollmentSeptember 1994

ConditionsDiabetic Foot Ulcer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Organogenesis
Enrollment: 281
Locations: 1
Primary Endpoint: Proportion of patients with 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 plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.

Registry

clinicaltrials.gov

Start Date

September 1994

End Date

January 1997

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 old or older.
•Patient has a current diagnosis of NIDDM or IDDM.
•Patient's ulcer is present for a minimum of two weeks under the current Investigator's care
•The study ulcer has healed \<50% in size during the two weeks leading up to randomization
•The study ulcer is on the plantar surface of the forefoot
•The ulcer is \>/= 1.0 cm2 at Day 0 (the day of randomization).
•The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
•The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting.
•The patient's Ankle-Arn Index by Doppler is \>0.1
•There is adequate circulation to the foot to allow for healing.

Exclusion Criteria

•Patient has clinical evidence of gangrene on any part of the affected foot.
•The ulcer is over a Charcot deformity.
•The ulcer has a nondiabetic etiology.
•The ulcer has tunnels or sinus tracts that cannot be completely debrided.
•The patient's diabetes is uncontrolled and could interfere with the completion of the study.
•There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study.
•Patient has/had a malignant disease not in remission for 5 years or more.
•Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of \<2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range.
•Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
•Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV).