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

NCT00368693 | Terminated Phase 3

• 2 other identifiers: Apopharma RS03-2004VA File #05-08-00364
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate.

  12 Weeks

Interventions

Dermal - Living Skin Replacement (Dermal-LSR) DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Full-thickness plantar ulcers (fore and mid foot only);
• Non-infected as determined by clinical assessment;
• Neuropathic as determined by monofilament assessment;
• Area ≥ 1.0 cm2 ≤ 25.0 cm2 post-debridement;
• Has been present for at least 8 weeks under a physician's observation at the time of enrollment;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

VA Medical Center

Mather, California, 95655, United States

Location

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Roslyn R Isseroff, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 25, 2006
• Study Start: August 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (2)