Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study

Foot Ankle Int. 2013 Oct;34(10):1332-9. doi: 10.1177/1071100713502179. Epub 2013 Aug 14.


Background: Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis.

Methods: An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being.

Results: Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM.

Conclusion: In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings.

Level of evidence: Level I, prospective randomized study.

Keywords: allografts; amniotic membrane; heel pain; micronized dehydrated human amniotic chorionic membrane; plantar fasciitis.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Allografts
  • Anesthetics, Local / administration & dosage
  • Biological Dressings*
  • Bupivacaine / administration & dosage
  • Chronic Disease
  • Fasciitis, Plantar / surgery*
  • Female
  • Health Status Indicators
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Prospective Studies
  • Sesquiterpenes
  • Standard of Care
  • Treatment Outcome


  • Anesthetics, Local
  • Sesquiterpenes
  • microlenin
  • Bupivacaine