Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181440
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Organogenesis

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE September 1994
Actual Primary Completion Date January 1997   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Proportion of patients with complete wound closure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Proportion of patients with complete wound closure [ Time Frame: 32 weeks ]
  • Time to reach 25%,50%,75%, and 100% of wound closure [ Time Frame: 32 weeks ]
  • Percent of wound healed [ Time Frame: 12 and 32 weeks ]
  • Wound characterization [ Time Frame: 32 weeks ]
  • Recurrence of the ulcer [ Time Frame: 32 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
Official Title  ICMJE A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • Device: Dermagraft(R)
    Weekly application of Dermagraft(R) with conventional care
    Other Name: human fibroblast derived dermal substitute
  • Other: Conventional care
    Weekly application of conventional care
    Other Name: standard of care, off-loading, surgical debridement, wet-to-moist dressing
Study Arms  ICMJE
  • Experimental: Dermagraft(R) and conventional care
    Intervention: Device: Dermagraft(R)
  • Conventional care only
    Intervention: Other: Conventional care
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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2010)
281
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1997
Actual Primary Completion Date January 1997   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181440
Other Study ID Numbers  ICMJE ABH-DG-04-04-0694
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Organogenesis
Study Sponsor  ICMJE Organogenesis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard A Pollak, DPM San Antonio Podiatry Associates, San Antonio, TX
PRS Account Organogenesis
Verification Date May 2018

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