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

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

Tracking Information

• First Submitted Date: August 12, 2010
• First Posted Date: August 13, 2010
• Last Update Posted Date: May 21, 2018
• Study Start Date: September 1994
• Actual Primary Completion Date: January 1997 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 12, 2010): Proportion of patients with complete wound closure [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment
• Condition: Diabetic Foot Ulcer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 12, 2010): 281
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 1997
• Actual Primary Completion Date: January 1997 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01181440
• Other Study ID Numbers: ABH-DG-04-04-0694
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Organogenesis
• Study Sponsor: Organogenesis
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard A Pollak, DPM; San Antonio Podiatry Associates, San Antonio, TX

• PRS Account: Organogenesis
• Verification Date: May 2018