Diabetic Foot Ulcer
Conditions
Keywords
Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Conventional care
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.
Interventions
DEVICEDermagraft(R)
Weekly application of Dermagraft(R) with conventional care
OTHERConventional care
Weekly application of conventional care
Sponsors
Organogenesis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete wound closure | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete wound closure | 32 weeks |
| Time to reach 25%,50%,75%, and 100% of wound closure | 32 weeks |
| Percent of wound healed | 12 and 32 weeks |
| Wound characterization | 32 weeks |
| Recurrence of the ulcer | 32 weeks |
Countries
United States
Outcome results
None listed