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)
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1
Richard Pollak, DPM
San Antonio, Texas, United States, 78229