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

This study has been completed.
Sponsor:
Information provided by:
Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT01181453
First received: August 12, 2010
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
Device: Dermagraft
Other: Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Shire Regenerative Medicine, Inc.:

Primary Outcome Measures:
  • Complete wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach complete wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent of wound closure by study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: December 1998
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermagraft(R)
Weekly application of Dermagraft(R) with standard care
Device: Dermagraft
Weekly application of Dermagraft(R) with standard care
Other Name: human fibroblast derived dermal substitute
Standard care only
Weekly application of standard care
Other: Comparator
Weekly application of standard care
Other Name: standard of care, off-loading, surgical debridement, wet-to-moist dressing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181453

Locations
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Shire Regenerative Medicine, Inc.
Investigators
Principal Investigator: William A Marston, MD University of North Carolina School of Medicine, Chapel Hill, NC
  More Information

Publications:
Responsible Party: Advanced BioHealing, Inc.
ClinicalTrials.gov Identifier: NCT01181453     History of Changes
Other Study ID Numbers: ABH-DG-04-07-0798
Study First Received: August 12, 2010
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire Regenerative Medicine, Inc.:
Diabetic foot ulcer
Randomized trial
Clinical trial
Dermagraft
Standard care

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 29, 2014