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Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

9. maj 2022 opdateret af: MiMedx Group, Inc.

A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Central Research Associates
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85710
        • Arizona Regional Medical Research (ARMR)
    • California
      • Carlsbad, California, Forenede Stater, 92009
        • ILD Research
      • Fresno, California, Forenede Stater, 93710
        • Limb Preservation Platform, Inc
      • Los Angeles, California, Forenede Stater, 90057
        • Foot and Ankle Clinic
    • Florida
      • Miami, Florida, Forenede Stater, 33143
        • Doctors Research Network
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30909
        • Joseph M. Still Burn Center at Doctors Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Advanced Foot & Ankle Center
    • Pennsylvania
      • Haverford, Pennsylvania, Forenede Stater, 19041
        • Foot and Ankle Center
    • Texas
      • McAllen, Texas, Forenede Stater, 78501
        • Futuro Clinical Trials
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Ambulatory Foot & Ankle Center, PC
      • Virginia Beach, Virginia, Forenede Stater, 23464
        • Costal Podiatry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

    1. Index Ulcer Assessment:

      1. Penetrates down totendon, or bone
      2. Presence of another diabetic foot ulcer within 3 cm of the index ulcer
      3. Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
      4. Exhibits clinical signs and symptoms of infection
      5. Known or suspected local skin malignancy to the index diabetic ulcer
      6. Wound duration > one year without intermittent closure

    2. Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:

      1. In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
      2. In the last 7 days - Hyperbaric oxygen (HBO) therapy
      3. In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
      4. 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
      5. 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.)
      6. In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
      7. In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot

    3. Subject criteria that will make subject ineligible for enrollment:

      1. Known osteomyelitis or active cellulitis at wound site
      2. Hemoglobin A1C >12 in the last 60 days prior to randomization
      3. History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
      4. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
      5. 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
      6. 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)
      7. Known history of poor compliance with medical treatments
      8. Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
      9. Subjects currently receiving radiation therapy or chemotherapy
      10. Patients currently on dialysis or planning to start dialysis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
Biologisk: EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
Aktiv komparator: Standard of Care
Weekly application of moist wound therapy and offloading
Andet: Standard of Care
moist wound therapy and offloading

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Ulcer Closure
Tidsramme: 12 weeks
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
12 weeks
Study Safety Measurement
Tidsramme: 12 weeks
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tid til at afslutte lukningen
Tidsramme: op til 12 uger
Som vurderet af fotografisk evaluering og efterforskeren
op til 12 uger
Rate af sårlukning
Tidsramme: op til 12 uger
Som vurderet af fotografisk evaluering og efterforskeren
op til 12 uger
Forekomst af tilbagefald af ulcus
Tidsramme: op til 12 uger
Forekomst af tilbagevendende ulcus på stedet for undersøgelsessåret
op til 12 uger
Quality of Life Health Survey
Tidsramme: up to 12 weeks
Change in quality of life metrics as measured by SF-36 Health Survey
up to 12 weeks
Quality of Life-Pain
Tidsramme: up to 12 weeks
Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
up to 12 weeks
Cost effectiveness of treatment
Tidsramme: up to 12 weeks
Cost effectiveness of treatment regime. looking at the number of grafts used on each study subject throughout the study.
up to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

MiMedx Group, Inc.

Efterforskere

  • Ledende efterforsker: William Tettelbach, MD, Intermountain Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2016

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først indsendt

8. juli 2016

Først indsendt, der opfyldte QC-kriterier

21. juli 2016

Først opslået (Skøn)

26. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2022

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ECDFU001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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