Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/23/2018 |
| Start Date: | September 1994 |
| End Date: | January 1997 |
A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
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.
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.
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.
- 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 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).
- 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.
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