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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85015
- Associated Foot and Ankle Specialists, LLC
-
-
California
-
Castro Valley, California, Stati Uniti, 94546
- Center for Clinical Research, Inc.
-
Stockton, California, Stati Uniti, 95204
- Pacific Wound Center
-
-
Florida
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Jacksonville, Florida, Stati Uniti, 32216
- First Coast Cardiovascular Institute
-
North Miami Beach, Florida, Stati Uniti, 33169
- Barry University Clinical Research
-
-
Massachusetts
-
Plymouth, Massachusetts, Stati Uniti, 02360
- Beth Israel Deaconess Hospital - Plymouth
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27710
- Duke University
-
Goldsboro, North Carolina, Stati Uniti, 27533
- Wayne Memorial Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: 8 weeks
|
8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to complete wound closure of the target ulcer
Lasso di tempo: 8 weeks
|
8 weeks
|
|
|
Rate of wound closure
Lasso di tempo: 8 Weeks
|
8 Weeks
|
|
|
Incidence, severity and type of adverse events
Lasso di tempo: 8 Weeks
|
This outcome measure represents a composite of collected adverse event data.
|
8 Weeks
|
|
Changes in Quality of Life assessment
Lasso di tempo: 8 Weeks
|
8 Weeks
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Malattie vascolari
- Malattia cardiovascolare
- Diabete mellito
- Ulcere del piede diabetico
- Complicazioni del diabete
- Angiopatie diabetiche
- Ferita
- Malattie del sistema endocrino
- Malattie della pelle
- Ulcera alla gamba
- Ulcera
- Ulcera della pelle
- Malattie del piede
- Ulcera del piede
- Piede diabetico
- Neuropatie diabetiche
- Salute del piede
- Ulcere del piede Wagner di grado 1 o 2
- AMNIOEXCEL
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DS2014.01.01
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