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

• ClinicalTrials.gov Identifier: NCT01181440
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: May 21, 2018
• Sponsor: Organogenesis
• Information provided by (Responsible Party): Organogenesis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Device: Dermagraft(R); Other: Conventional care	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 281 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
• Study Start Date: September 1994
• Actual Primary Completion Date: January 1997
• Actual Study Completion Date: January 1997

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dermagraft(R) and conventional care	Device: Dermagraft(R); Weekly application of Dermagraft(R) with conventional care; Other Name: human fibroblast derived dermal substitute
Conventional care only	Other: Conventional care; Weekly application of conventional care; Other Name: standard of care, off-loading, surgical debridement, wet-to-moist dressing

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients with complete wound closure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Proportion of patients with complete wound closure [ Time Frame: 32 weeks ]
2. Time to reach 25%,50%,75%, and 100% of wound closure [ Time Frame: 32 weeks ]
3. Percent of wound healed [ Time Frame: 12 and 32 weeks ]
4. Wound characterization [ Time Frame: 32 weeks ]
5. Recurrence of the ulcer [ Time Frame: 32 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Richard Pollak, DPM

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Organogenesis

Investigators

• Principal Investigator: Richard A Pollak, DPM; San Antonio Podiatry Associates, San Antonio, TX

More Information

Publications of Results:

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

Other 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

• Responsible Party: Organogenesis
• ClinicalTrials.gov Identifier: NCT01181440
• Other Study ID Numbers: ABH-DG-04-04-0694
• First Posted: August 13, 2010
• Last Update Posted: May 21, 2018
• Last Verified: May 2018

Keywords provided by Organogenesis:

Diabetic foot ulcer; Randomized trial; Clinical trial; Dermagraft; Conventional care

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases