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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. Identifier: NCT01181440
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : May 21, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Dermagraft(R) Other: Conventional care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
Study Start Date : September 1994
Actual Primary Completion Date : January 1997
Actual Study Completion Date : January 1997

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of patients with complete wound closure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients with complete wound closure [ Time Frame: 32 weeks ]
  2. Time to reach 25%,50%,75%, and 100% of wound closure [ Time Frame: 32 weeks ]
  3. Percent of wound healed [ Time Frame: 12 and 32 weeks ]
  4. Wound characterization [ Time Frame: 32 weeks ]
  5. Recurrence of the ulcer [ Time Frame: 32 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01181440

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United States, Texas
Richard Pollak, DPM
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Principal Investigator: Richard A Pollak, DPM San Antonio Podiatry Associates, San Antonio, TX
Publications of Results:
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

Other 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

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Responsible Party: Organogenesis Identifier: NCT01181440    
Other Study ID Numbers: ABH-DG-04-04-0694
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Keywords provided by Organogenesis:
Diabetic foot ulcer
Randomized trial
Clinical trial
Conventional care
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases