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

Diabetic Foot Ulcer Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181440
• Other study ID #: ABH-DG-04-04-0694
• Status: Completed
• Phase: Phase 3
• Start date: September 1994
• Est. completion date: January 1997

Study information

• Verified date: May 2018
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: January 1997
• Est. primary completion date: January 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Dermagraft(R)
Weekly application of Dermagraft(R) with conventional care

Other:
• Conventional care
Weekly application of conventional care

Locations

Country	Name	City	State
United States	Richard Pollak, DPM	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with complete wound closure		12 weeks
Secondary	Proportion of patients with complete wound closure		32 weeks
Secondary	Time to reach 25%,50%,75%, and 100% of wound closure		32 weeks
Secondary	Percent of wound healed		12 and 32 weeks
Secondary	Wound characterization		32 weeks
Secondary	Recurrence of the ulcer		32 weeks