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

NCT01181453 | Completed Phase 3

• 1 other identifier: ABH-DG-04-07-0798
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete wound closure

  12 weeks

Secondary Outcomes (2)

• Time to reach complete wound closure

  12 weeks

• Percent of wound closure by study end

  12 weeks

Study Arms (2)

Dermagraft(R)

EXPERIMENTAL

Weekly application of Dermagraft(R) with standard care

Device: Dermagraft

Standard care only

OTHER

Weekly application of standard care

Other: Comparator

Interventions

Dermagraft DEVICE

Weekly application of Dermagraft(R) with standard care

Also known as: human fibroblast derived dermal substitute

Dermagraft(R)

Comparator OTHER

Weekly application of standard care

Also known as: standard of care, off-loading, surgical debridement, wet-to-moist dressing

Standard care only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 12766097 RESULT

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William A Marston, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: December 1, 1998
• Primary Completion: March 1, 2000
• Study Completion: March 1, 2000
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)