- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02209051
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.
Upon return, per the original protocol, patient would have been randomized at <20% closure; per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.
All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.
The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.
This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85015
- Associated Foot and Ankle Specialists, LLC
-
-
California
-
Castro Valley, California, Forente stater, 94546
- Center for Clinical Research, Inc.
-
Stockton, California, Forente stater, 95204
- Pacific Wound Center
-
-
Florida
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Jacksonville, Florida, Forente stater, 32216
- First Coast Cardiovascular Institute
-
North Miami Beach, Florida, Forente stater, 33169
- Barry University Clinical Research
-
-
Massachusetts
-
Plymouth, Massachusetts, Forente stater, 02360
- Beth Israel Deaconess Hospital - Plymouth
-
-
North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University
-
Goldsboro, North Carolina, Forente stater, 27533
- Wayne Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- an ambulatory person at least 18 years of age at the time of informed consent.
- type 1 or type 2 diabetes mellitus.
- glycosylated hemoglobin (HbA1c) of ≤12%
at least one wound that is/has:
- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
- duration of at least 1 month,
- no clinical signs of infection or osteomyelitis,
- between 1cm2 and 25cm2 in area,
- per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
- located on the foot, distal to malleoli.
- adequate circulation to the affected extremity
- serum creatinine of <3.0mg/dl.
Exclusion Criteria:
- participated in another clinical trial within 30 days prior to consent,
- Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
- receiving radiation or chemotherapy of any kind,
- known or suspected malignancy of current ulcer,
- pregnant or breast feeding,
- an active malignant disease,
- receiving hemo- or peritoneal dialysis,
- sickle cell anemia or Raynaud's syndrome,
- diagnosis of autoimmune connective tissue disease,
- received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
- exposed bone, tendon or joint capsule in the study ulcer,
- currently receiving antibiotics (for any reason), or
- taking medications considered to be immune system modulators.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: AMNIOEXCEL
Human Amniotic Membrane Allograft
|
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
Aktiv komparator: Standard of Care, Diabetic Foot Ulcers
Advanced wound care dressings and offloading of wound.
|
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
Tidsramme: 8 weeks
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to complete wound closure of the target ulcer
Tidsramme: 8 weeks
|
8 weeks
|
|
Rate of wound closure
Tidsramme: 8 Weeks
|
8 Weeks
|
|
Incidence, severity and type of adverse events
Tidsramme: 8 Weeks
|
This outcome measure represents a composite of collected adverse event data.
|
8 Weeks
|
Changes in Quality of Life assessment
Tidsramme: 8 Weeks
|
8 Weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Sukkersyke
- Diabetiske fotsår
- Diabetes komplikasjoner
- Diabetiske angiopatier
- Sår
- Sykdommer i det endokrine systemet
- Hudsykdommer
- Bensår
- Magesår
- Hudsår
- Fotsykdommer
- Fotsår
- Diabetisk fot
- Diabetiske nevropatier
- Fothelse
- Wagner Grad 1 eller 2 fotsår
- AMNIOEXCEL
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DS2014.01.01
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