Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368693
First received: August 24, 2006
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.


Condition Intervention Phase
Diabetic Foot Ulcer
Device: Dermal - Living Skin Replacement (Dermal-LSR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pivotal Study to Evaluate the Efficacy and Safety of Dermal - Living Skin Replacement (Dermal - LSR) in the Treatment of Chronic Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Dermal - Living Skin Replacement (Dermal-LSR)
    The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator.
Detailed Description:

This prospective, randomized, controlled, open-label, multi-center study will test the efficacy of Dermal - Living Skin Replacement (Dermal - LSR) plus standard of care treatment against solely the standard of care treatment on participants with diabetic foot ulcers.

The purpose of this study is to test Dermal - LSR combined with standard treatment. We want to see how well it works and the number and types of side effects, if any. We hope to learn more about how to heal diabetic foot ulcers better.

You will:

  • be interviewed and examined
  • have weekly clinic visits
  • have blood drawn
  • have the ulcer photographed
  • wear a walking boot to reduce pressure on the ulcer
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have Type I or Type II diabetes
  • Signed informed consent obtained from subject or legal guardian/representative prior to the first study intervention.
  • Age ≥ 18 and < 85 years old at the time the informed consent is signed.
  • Subjects will have a diabetic ulcer on the lower extremity, with the ulcer having all of the following characteristics:

    1. Full-thickness plantar ulcers (fore and mid foot only);
    2. Non-infected as determined by clinical assessment;
    3. Neuropathic as determined by monofilament assessment;
    4. Area ≥ 1.0 cm2 ≤ 25.0 cm2 post-debridement;
    5. Has been present for at least 8 weeks under a physician's observation at the time of enrollment;
    6. Extends through the dermis but without tendon, muscle, capsule or bone exposure.
  • Subjects will have only one diabetic foot ulcer on the target limb.
  • Subjects will have either insulin-dependent or non-insulin-dependent diabetes mellitus (Type I or Type II, respectively) with a HbA1C value in the range of 6% to 12%.
  • The ulcer bed at the time of enrollment must be free of all necrotic and infected soft and bony tissue as determined by clinical examination (no evidence of probing to bone) and by X-ray films.
  • Ankle-brachial systolic pressure index between 0.7 and 1.3. If the value is > 1.3, then a transcutaneous partial pressure of oxygen (TcPO2) of ≥ 40 mmHg OR a toe pressure of ≥ 50 mmHg must be obtained for subject to be eligible.
  • Female subjects must have a negative serum pregnancy test prior to the first treatment.

Exclusion Criteria:

  • Known or suspected disease of the immune system currently under investigation, other than Diabetes Mellitus.
  • Active or untreated malignancy or active, uncontrolled connective tissue disease.
  • Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrollment.
  • Presence of necrosis, purulence or sinus tracts that cannot be removed by treatment.
  • Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to enrollment.
  • Active febrile illness (fever ≥ 38.0 ºC p.o.).
  • Renal or liver impairment as indicated by serum creatinine levels and liver function tests three or more times higher than the normal values.
  • Osteomyelitis diagnosed by exposed bone and by radiological investigations.
  • Subject has an active Charcot as determined by the clinical examination (new local pain, evidence of swelling and warmth).
  • Subjects who refuse or who are unable to participate in all screening procedures, or to comply with the requirements of the study.
  • Use of other investigational products at the time of enrollment or during the study.
  • The use of any topical treatments, other than SOC, in or on the surface of the target ulcer at the time of enrollment.
  • Subjects who have been enrolled in any investigational clinical trial within 30 days of the screening visit.
  • Currently pregnant or lactating, or planning a pregnancy to occur during the study period.
  • Known allergic reactions, including dermatological hypersensitivity, to any study product components.
  • Recent or current history of alcohol or drug abuse.
  • Subjects who, in the opinion of the Investigator, represent poor medical, psychological or psychiatric risks for whom therapy with an investigational product would be unwise.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368693

Locations
United States, California
VA Medical Center
Mather, California, United States, 95655
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Roslyn R Isseroff, M.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Roslyn R. Isseroff, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00368693     History of Changes
Other Study ID Numbers: Apopharma RS03-2004, VA File #05-08-00364
Study First Received: August 24, 2006
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 28, 2014