Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT01181440 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : May 21, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Foot Ulcer | Device: Dermagraft(R) Other: Conventional care | Phase 3 |
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 |

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 |
- Proportion of patients with complete wound closure [ Time Frame: 12 weeks ]
- 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 ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT01181440
United States, Texas | |
Richard Pollak, DPM | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Richard A Pollak, DPM | San Antonio Podiatry Associates, San Antonio, TX |
Other Publications:
Responsible Party: | Organogenesis |
ClinicalTrials.gov 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 |
Diabetic foot ulcer Randomized trial Clinical trial Dermagraft Conventional care |
Diabetic Foot Foot Ulcer 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 |