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- Klinische proef NCT02844660
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35205
- Central Research Associates
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Arizona
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Tucson, Arizona, Verenigde Staten, 85710
- Arizona Regional Medical Research (ARMR)
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California
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Carlsbad, California, Verenigde Staten, 92009
- ILD Research
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Fresno, California, Verenigde Staten, 93710
- Limb Preservation Platform, Inc
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Los Angeles, California, Verenigde Staten, 90057
- Foot and Ankle Clinic
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Florida
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Miami, Florida, Verenigde Staten, 33143
- Doctors Research Network
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Georgia
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Augusta, Georgia, Verenigde Staten, 30909
- Joseph M. Still Burn Center at Doctors Hospital
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70121
- Ochsner Clinic Foundation
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89119
- Advanced Foot & Ankle Center
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Pennsylvania
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Haverford, Pennsylvania, Verenigde Staten, 19041
- Foot and Ankle Center
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Texas
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McAllen, Texas, Verenigde Staten, 78501
- Futuro Clinical Trials
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Virginia
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Hampton, Virginia, Verenigde Staten, 23666
- Ambulatory Foot & Ankle Center, PC
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Virginia Beach, Virginia, Verenigde Staten, 23464
- Costal Podiatry
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
2. Index ulcer characteristics:
a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
4. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
- ABIs with results of ≥ 0.7 and ≤ 1.2, OR
Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Index Ulcer Assessment:
- Penetrates down totendon, or bone
- Presence of another diabetic foot ulcer within 3 cm of the index ulcer
- Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
- Exhibits clinical signs and symptoms of infection
- Known or suspected local skin malignancy to the index diabetic ulcer
- Wound duration > one year without intermittent closure
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
- In the last 7 days - Hyperbaric oxygen (HBO) therapy
- In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot
Subject criteria that will make subject ineligible for enrollment:
- Known osteomyelitis or active cellulitis at wound site
- Hemoglobin A1C >12 in the last 60 days prior to randomization
- History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Known history of poor compliance with medical treatments
- Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
- Subjects currently receiving radiation therapy or chemotherapy
- Patients currently on dialysis or planning to start dialysis
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
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Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
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Actieve vergelijker: Standard of Care
Weekly application of moist wound therapy and offloading
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moist wound therapy and offloading
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Complete Ulcer Closure
Tijdsspanne: 12 weeks
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The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
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12 weeks
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Study Safety Measurement
Tijdsspanne: 12 weeks
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The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
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12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Tijd om de sluiting te voltooien
Tijdsspanne: tot 12 weken
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Zoals beoordeeld door fotografische evaluatie en de onderzoeker
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tot 12 weken
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Snelheid van wondsluiting
Tijdsspanne: tot 12 weken
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Zoals beoordeeld door fotografische evaluatie en de onderzoeker
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tot 12 weken
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Incidentie van terugkerende ulcera
Tijdsspanne: tot 12 weken
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Incidentie van terugkerende zweren op de plaats van de onderzoekszweer
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tot 12 weken
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Quality of Life Health Survey
Tijdsspanne: up to 12 weeks
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Change in quality of life metrics as measured by SF-36 Health Survey
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up to 12 weeks
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Quality of Life-Pain
Tijdsspanne: up to 12 weeks
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Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
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up to 12 weeks
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Cost effectiveness of treatment
Tijdsspanne: up to 12 weeks
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Cost effectiveness of treatment regime.
looking at the number of grafts used on each study subject throughout the study.
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up to 12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: William Tettelbach, MD, Intermountain Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ECDFU001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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