Clinical Publications

  1. "A prospective, randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers.”
    Charles Zelen, Thomas E Serena, Robert J Snyder
    International Wound Journal, June 7, 2013. DOI: 10.1111/iwj.12242
    Institutional review board-approved, registered, prospective, randomized, comparative clinical trial involving patients with diabetic foot ulcers (DFUs). Patients were enrolled following a 2-week run-in period, after having been treated with 4 weeks of conventional therapy.  Those patients exhibiting rapid healing (wound reduction of more than 50%) at the conclusion of 'run-in period' were excluded. EpiFix® was either utilized weekly or bi-weekly on 40 patients.  In both groups, EpiFix® achieved wound closure in 70% of patients in 4 weeks.  In addition, 92.5% of the overall population exhibited healing at 12 weeks with EpiFix®. The mean time to closure for the weekly applications was 17 days, and 25 days for bi-weekly applications.
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  2. "A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers”
    Charles Zelen, DPM, FACFAS, FACFAOM, et al
    International Wound Journal, October 2013. DOI: 10.1111/iwj.12097
    The publication details results from a study of patients with a diabetic foot ulcer treated with EpiFix®. Patients enrolled in this crossover study had been randomized to receive standard care in the previously reported clinical trial which compared treatment with EpiFix to standard care. In this randomized clinical trial (RCT) the overall healing rate with application of EpiFix® was shown to be 77% and 92% after 4 and 6 weeks of treatment respectively, whereas standard care healed 0% and 8% of the wounds, respectively.
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  3. "An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs”
    Charles Zelen, DPM, FACFAS, FACFAOM
    Journal of Wound Care, July 2013 (Vol. 22, Iss. 7, 11 Jul 2013, pp 347 – 351)
    At completion of the RCT patients that did not heal with standard care were then offered treatment with EpiFix. Although wounds had been present for an average of over 21 weeks, when treatment with EpiFix was initiated complete healing was achieved in 55% of patients within 4 weeks, 64% within 6 weeks, and 91% within 9 weeks. These results provide additional evidence that using EpiFix® in addition to standard care effectively promotes wound healing.
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  4. “Prospective, Randomized, Blinded, Comparative Study of Injectable Micronized Dehydrated Amniotic/Chorionic Membrane Allograft for Plantar Fasciitis—A Feasibility Study”
    Charles M. Zelen, DPM, Attila Poka, MD, and James Andrews, MD
    Foot & Ankle International, ePub August  2013
    The randomized clinical trial examined the efficacy of dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for the inflammation associated with chronic refractory plantar fasciitis. The study determined that this injection for plantar fasciitis can reduce inflammation and promote healing and may be an alternative to surgical intervention.
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  5. "Scientific and Clinical Support for the Use of Dehydrated Amniotic Membrane in Wound Management"
    Donald E. Fetterolf, MD and Robert J. Snyder, DPM, MSc
    WOUNDS 2012;24(10):299–307
    Details the history of amniotic membrane use in clinical applications and new techniques for dehydrating the material while preserving the structural components and key elements contained within the amniotic membrane important for wound healing.
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  6. "Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series"
    J. Forbes, D.O., CWS and D.E. Fetterolf, MD
    Journal of Wound Care, Volume 21. Number 6. June 2012
    A retrospective case series demonstrating the use of dehydrated human amnion/ chorion membrane (dHACM) allografts in the treatment of wounds of various etiologies. Wounds treated with the amniotic membrane allograft demonstrated improved healing.
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  7. "Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds"
    Emran S Sheikh, Ednan S Sheikh & Donald E Fetterolf
    International Wound Journal ISSN 1742-4801, February 2013.
    Description of the treatment of refractory nonhealing wounds with EpiFix(R) dehydrated human amnion/chorion membrane (dHACM) allograft.
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