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

NCT01181440 | Completed Phase 3

• 1 other identifier: ABH-DG-04-04-0694
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic foot ulcer; Randomized trial; Clinical trial; Dermagraft; Conventional care

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete wound closure

  12 weeks

Secondary Outcomes (5)

• Proportion of patients with complete wound closure

  32 weeks

• Time to reach 25%,50%,75%, and 100% of wound closure

  32 weeks

• Percent of wound healed

  12 and 32 weeks

• Wound characterization

  32 weeks

• Recurrence of the ulcer

  32 weeks

Study Arms (2)

Dermagraft(R) and conventional care

EXPERIMENTAL

Device: Dermagraft(R)

Conventional care only

OTHER

Other: Conventional care

Interventions

Dermagraft(R) DEVICE

Weekly application of Dermagraft(R) with conventional care

Also known as: human fibroblast derived dermal substitute

Dermagraft(R) and conventional care

Conventional care OTHER

Weekly application of conventional care

Also known as: standard of care, off-loading, surgical debridement, wet-to-moist dressing

Conventional care only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

Richard Pollak, DPM

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Naughton G, Mansbridge J, Gentzkow G. A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Artif Organs. 1997 Nov;21(11):1203-10. doi: 10.1111/j.1525-1594.1997.tb00476.x.

  PMID: 9384327 BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Richard A Pollak, DPM

  San Antonio Podiatry Associates, San Antonio, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: September 1, 1994
• Primary Completion: January 1, 1997
• Study Completion: January 1, 1997
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)