Status:
COMPLETED
Pivotal Trial of Dermagraft(R) to Treat 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 diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). D...
Eligibility Criteria
Inclusion
- 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 \>/=0.7.
- 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.
- 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 before treatment.
- Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit.
Exclusion
- 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 \<2.0.
- Presence of patient having known alcohol or drug abuse.
- A random blood sugar reading \>/=450 mg/dL.
- Presence of urine ketones that are noted to be "Small, Moderate, or Large".
- Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0.
- Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study.
- A history of bleeding disorder.
- Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).
- Participation in another study involving treatment with an investigational product within the previous 30 days.
- Elective osseous procedures to the study foot within 30 days prior to the Screening visit.
- Previous treatment with Dermagraft®.
- Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.
- Presence of condition(s) that seriously compromise the patient's ability to complete this study.
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2000
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT01181453
Start Date
December 1 1998
End Date
March 1 2000
Last Update
May 21 2018
Active Locations (1)
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1
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27514