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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

August 12, 2010
August 9, 2013
December 1998
March 2000   (final data collection date for primary outcome measure)
Complete wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01181453 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • Device: Dermagraft
    Weekly application of Dermagraft(R) with standard care
    Other Name: human fibroblast derived dermal substitute
  • Other: Comparator
    Weekly application of standard care
    Other Name: standard of care, off-loading, surgical debridement, wet-to-moist dressing
  • Experimental: Dermagraft(R)
    Weekly application of Dermagraft(R) with standard care
    Intervention: Device: Dermagraft
  • Standard care only
    Weekly application of standard care
    Intervention: Other: Comparator
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
March 2000
March 2000   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01181453
ABH-DG-04-07-0798
Not Provided
Advanced BioHealing, Inc.
Shire Regenerative Medicine, Inc.
Not Provided
Principal Investigator: William A Marston, MD University of North Carolina School of Medicine, Chapel Hill, NC
Shire Regenerative Medicine, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP