Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Dermagraft(R); Other: Conventional care

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Richard Pollak, DPM

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 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.

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) and conventional care	Device: Dermagraft(R); Weekly application of Dermagraft(R) with conventional care; Other Names: human fibroblast derived dermal substitute
OTHER: Conventional care only	Other: Conventional care; Weekly application of conventional 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
Proportion of patients with complete wound closure	12 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Principal Investigator: Richard A Pollak, DPM, San Antonio Podiatry Associates, San Antonio, TX

Publications and helpful links

General Publications

• Pollak RA, Edington H, Jensen JL, Kroeker RO, Gentzkow GD. A human dermal replacement for the treatment of diabetic foot ulcers. Wounds. 1997;9:175-183
• Gentzkow GD, Jensen JL, Pollak RA, Kroeker RO, Lerner JM, Lerner M, Iwasaki SD, the Dermagraft Diabetic Ulcer Study Group. Improved healing of diabetic foot ulcers after grafting with a living human dermal replacement. Wounds. 1999;11:77-84

Study record dates

Study Major Dates

• Study Start: September 1, 1994
• Primary Completion (ACTUAL): January 1, 1997
• Study Completion (ACTUAL): January 1, 1997

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; Conventional 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-04-04-0694