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

This study has been completed.
Sponsor:
Information provided by:
Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT01181440
First received: August 12, 2010
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
Device: Dermagraft(R)
Other: Conventional care
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 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:
  • Proportion of patients with complete wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with complete wound closure [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Time to reach 25%,50%,75%, and 100% of wound closure [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Percent of wound healed [ Time Frame: 12 and 32 weeks ] [ Designated as safety issue: No ]
  • Wound characterization [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Recurrence of the ulcer [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: September 1994
Study Completion Date: January 1997
Primary Completion Date: January 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181440

Locations
United States, Texas
Richard Pollak, DPM
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Shire Regenerative Medicine, Inc.
Investigators
Principal Investigator: Richard A Pollak, DPM San Antonio Podiatry Associates, San Antonio, TX
  More Information

Publications:
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
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: Advanced BioHealing, Inc.
ClinicalTrials.gov Identifier: NCT01181440     History of Changes
Other Study ID Numbers: ABH-DG-04-04-0694
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
Conventional 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 April 15, 2014