- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368693
Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers
Pivotal Study to Evaluate the Efficacy and Safety of Dermal - Living Skin Replacement (Dermal - LSR) in the Treatment of Chronic Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Mather, California, United States, 95655
- VA Medical Center
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Sacramento, California, United States, 95816
- University of California, Davis Medical Center Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete ulcer closure will be defined as complete re-epithelialization without the presence of any callus and/or exudate.
Time Frame: 12 Weeks
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roslyn R Isseroff, M.D., University of California, Davis
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Apopharma RS03-2004
- VA File #05-08-00364
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
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University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
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Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
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Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
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Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
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Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
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National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
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ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
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University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
Clinical Trials on Dermal - Living Skin Replacement (Dermal-LSR)
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ApoPharmaTerminatedDiabetic Foot UlcerUnited States
-
Universitair Ziekenhuis BrusselOrganisation for Burns, Scar Aftercare and ResearchCompleted
-
Smart Matrix LimitedWelsh Centre for Burns and Plastic Surgery, Swansea, UK; Queen Victoria Hospital...TerminatedBasal Cell Carcinoma | Squamous Cell CarcinomaUnited Kingdom
-
Integra LifeSciences CorporationTerminatedFoot Ulcer, DiabeticUnited States
-
University Hospital, GhentResearch Foundation FlandersCompletedBurns | Necrotizing Fascitis | Full Thickness BurnBelgium
-
First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
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Euro Tissue BankDutch Burns FoundationTerminatedFull-thickness Skin Loss Due to Burn, Unspecified SiteSpain, Netherlands, Belgium, Greece
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Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester and other collaboratorsTerminatedVenous Ulcer | AllograftUnited Kingdom
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RHEACELL GmbH & Co. KGFGK Clinical Research GmbHRecruitingSkin Ulcer Venous Stasis ChronicGermany
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Mirka LtdClinius LtdCompletedKeratosis, Actinic | Hyperkeratotic Callus | Actinic Lesion | Solar Keratosis/Sunburn | Hyperkeratosis | Hyperkeratotic; Lesion | Hyperkeratotic Actinic KeratosisFinland