Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Lead Sponsor:

Organogenesis

Conditions:

Diabetic Foot Ulcer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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.
  • The patient's diabetes is under control as determined by the Investigator.
  • Female patients capable of bearing children must test negative for pregnancy and must use an acceptable means of birth control.
  • Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.
  • Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form.

Exclusion

  • 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).
  • Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
  • The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection.
  • Patient has any condition(s) which seriously compromises their ability to complete this study.

Key Trial Info

Start Date :

September 1 1994

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 1997

Estimated Enrollment :

281 Patients enrolled

Trial Details

Trial ID

NCT01181440

Start Date

September 1 1994

End Date

January 1 1997

Last Update

May 21 2018

Active Locations (1)

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

Page 1 of 1 (1 locations)

1

Richard Pollak, DPM

San Antonio, Texas, United States, 78229