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

A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Dermagraft; Other: Comparator

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dermagraft(R); Weekly application of Dermagraft(R) with standard care	Device: Dermagraft; Weekly application of Dermagraft(R) with standard care; Other Names: human fibroblast derived dermal substitute
OTHER: Standard care only; Weekly application of standard care	Other: Comparator; Weekly application of standard care; Other Names: standard of care, off-loading, surgical debridement, wet-to-moist dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete wound closure	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach complete wound closure	12 weeks
Percent of wound closure by study end	12 weeks

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Principal Investigator: William A Marston, MD, University of North Carolina School of Medicine, Chapel Hill, NC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 1998
• Primary Completion (ACTUAL): March 1, 2000
• Study Completion (ACTUAL): March 1, 2000

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (ESTIMATE): August 13, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Clinical trial; Randomized trial; Dermagraft; Standard care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: ABH-DG-04-07-0798