A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers
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Le résumé fourni par la source
ulcer located below the ankle that had been persisting for at least 30 days were eligible for the 14-day study run-in phase. After 14 days of weekly debridement, moist wound therapy, and off-loading, those with ≤30% wound area reduction post-debridement (n = 155) were randomised in a 2:1 ratio to receive a weekly application of EpiCord (n = 101) or standardised therapy with alginate wound dressing, non-adherent silicone dressing, absorbent non-adhesive hydropolymer secondary dressing, and gauze bandage roll (n = 54). All wounds continued to have appropriate off-loading during the treatment phase of the study. Study visits were conducted for 12 weeks. At each weekly visit, the DFU was cleaned and debrided as necessary, with the wound photographed pre- and post-debridement and measured before the application of treatment group-specific dressings. A follow-up visit was performed at week 16. The primary study end point was the percentage of complete closure of the study ulcer within 12 weeks, as assessed by Silhouette camera. Data for randomised subjects meeting study inclusion criteria were included in an intent-to-treat (ITT) analysis. Additional analysis was conducted on a group of subjects (n = 134) who completed the study per protocol (PP) (EpiCord, n = 86, alginate, n = 48) and for those subjects receiving adequate debridement (EpiCord, n = 67, alginate, n = 40). ITT analysis showed that DFUs treated with EpiCord were more likely to heal within 12 weeks than those receiving alginate dressings, 71 of 101 (70%) vs 26 of 54 (48%) for EpiCord and alginate dressings, respectively, P = 0.0089. Healing rates at 12 weeks for subjects treated PP were 70 of 86 (81%) for EpiCord-treated and 26 of 48 (54%) for alginate-treated DFUs, P = 0.0013. For those DFUs that received adequate debridement (n = 107, ITT population), 64 of 67 (96%) of the EpiCord-treated ulcers healed completely within 12 weeks, compared with 26 of 40 (65%) of adequately debrided alginate-treated ulcers, P < 0.0001. Seventy-five subjects experienced at least one adverse event, with a total of 160 adverse events recorded. There were no adverse events related to either EpiCord or alginate dressings. These results demonstrate the safety and efficacy of EpiCord as a treatment for non-healing DFUs.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers
- Date Crossref
- 24/09/2018
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Intermountain Healthcare Wound Care & pays non établi dans la noticeÉtablissement de santé
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Heritage Preservation pays non établi dans la noticeOrganisation à but non lucratif
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American Orthopaedic Foot and Ankle Society pays non établi dans la noticeOrganisation à but non lucratif
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University Foot & Ankle Institute pays non établi dans la noticeInstitution
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Futuro pays non établi dans la noticeOrganisation à but non lucratif
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Clinical Trials of Texas pays non établi dans la noticeStructure de recherche
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Podiatry Institute pays non établi dans la noticeOrganisation à but non lucratif
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Orthopedic Foot & Ankle Center pays non établi dans la noticeÉtablissement de santé
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Inc. Fresno California Limb Preservation Platform pays non établi dans la noticeEntreprise
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Foot and Ankle Clinic Los Angeles California pays non établi dans la noticeÉtablissement de santé
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Inc Virginia Beach Virginia Coastal Podiatry pays non établi dans la noticeEntreprise
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Miami Foot and Ankle Miami Florida pays non établi dans la noticeInstitution
Wound Care & — Intermountain Healthcare, Heritage Preservation et American Orthopaedic Foot and Ankle Society, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.