Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane.

MedStar author(s):
Citation: Wounds-A Compendium of Clinical Research & Practice. 30(9):283-289, 2018 Sep.PMID: 30256747Institution: MedStar Washington Hospital CenterDepartment: Surgery/Orthopaedic Surgery | Surgery/Plastic Surgery | Surgery/Podiatric SurgeryForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Biological Dressings | *Cryopreservation | *Diabetic Foot/th [Therapy] | *Placenta/tr [Transplantation] | *Wound Healing/ph [Physiology] | Aged | Diabetic Foot/co [Complications] | Female | Humans | Male | Middle Aged | Pregnancy | Treatment OutcomeYear: 2018ISSN:
  • 1044-7946
Name of journal: Wounds : a compendium of clinical research and practiceAbstract: CONCLUSIONS: These results corroborate the benefits of this CPM combined with SWC over SWC alone for chronic DFUs previously reported for the blinded randomized phase of the trial, which directly relate to lower health care costs.MATERIALS AND METHODS: Twenty-six patients in the standard wound care (SWC) arm whose DFUs did not close in the blinded phase chose to receive weekly applications of the CPM in an open-label extension phase.OBJECTIVE: The results of the single-arm, open-label extension phase of the Grafix (cryopreserved placental membrane; CPM; Osiris Therapeutics, Inc, Columbia, MD) multicenter, blinded, randomized, controlled clinical trial for chronic diabetic foot ulcers (DFUs) is reported.RESULTS: In the extension phase, 17 (65.4%) patients closed their wounds in a median of 34 days and 3 visits. There were fewer total adverse events (AEs) (24 CPM vs. 52 SWC) and index wound-related infections (5 CPM vs. 12 SWC) during the CPM application compared with the number of AEs for the same patients during the SWC treatment in the blinded phase of the trial.All authors: Anghel EL, Attinger CE, Cinque M, DeFazio MV, Economides JM, Evans KK, Golshani K, Hung R, Lakhiani CFiscal year: FY2019Date added to catalog: 2018-11-02
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Journal Article MedStar Authors Catalog Article 30256747 Available 30256747

CONCLUSIONS: These results corroborate the benefits of this CPM combined with SWC over SWC alone for chronic DFUs previously reported for the blinded randomized phase of the trial, which directly relate to lower health care costs.

MATERIALS AND METHODS: Twenty-six patients in the standard wound care (SWC) arm whose DFUs did not close in the blinded phase chose to receive weekly applications of the CPM in an open-label extension phase.

OBJECTIVE: The results of the single-arm, open-label extension phase of the Grafix (cryopreserved placental membrane; CPM; Osiris Therapeutics, Inc, Columbia, MD) multicenter, blinded, randomized, controlled clinical trial for chronic diabetic foot ulcers (DFUs) is reported.

RESULTS: In the extension phase, 17 (65.4%) patients closed their wounds in a median of 34 days and 3 visits. There were fewer total adverse events (AEs) (24 CPM vs. 52 SWC) and index wound-related infections (5 CPM vs. 12 SWC) during the CPM application compared with the number of AEs for the same patients during the SWC treatment in the blinded phase of the trial.

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