Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

NCT ID: NCT01181453

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31
• Study Completion Date: 2000-03-31

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). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dermagraft(R)

Weekly application of Dermagraft(R) with standard care

Group Type: EXPERIMENTAL

Dermagraft

Intervention Type: DEVICE

Weekly application of Dermagraft(R) with standard care

Standard care only

Weekly application of standard care

Group Type: OTHER

Comparator

Intervention Type: OTHER

Weekly application of standard care

Interventions

Dermagraft

Weekly application of Dermagraft(R) with standard care

Intervention Type: DEVICE

Comparator

Weekly application of standard care

Intervention Type: OTHER

Other Intervention Names

human fibroblast derived dermal substitute; standard of care, off-loading, surgical debridement, wet-to-moist dressing

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William A Marston, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina School of Medicine, Chapel Hill, NC

Locations

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

References

Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5. doi: 10.2337/diacare.26.6.1701.

Reference Type: RESULT

PMID: 12766097 (View on PubMed)

Other Identifiers

ABH-DG-04-07-0798

Identifier Type: -

Identifier Source: org_study_id