Researchers just published the results of a randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of Plantar Fasciitis. Their study was published in Foot & Ankle International. For the study, Subjects were randomized to receive 1 injection, in the affected area, of micronized dHACM (n=73) or 0.9% sodium chloride placebo (n=72). Safety/efficacy assessments were conducted at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months postinjection, using visual analog scale (VAS) for pain, Foot Function Index–Revised (FFI-R) score, and presence/absence of adverse events. Primary outcome was mean change in VAS score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Secondary outcome was mean change in FFI-R score between baseline and 3 months expressed as difference in means for treatment versus control subjects.
The authors reported that Baseline VAS scores were similar between groups. At the 3-month follow-up, mean VAS scores in the treatment group were 76% lower compared with a 45% reduction for controls (P < .0001), FFI-R scores for treatment subjects had mean reduction of 60% versus baseline, whereas control subjects had mean reduction of 40% versus baseline (P = .0004). Of 4 serious adverse events, none were related to study procedures.
This is an important study showing the pain reduction and functional improvement outcomes that can be achieved in clinical practice using this emerging regenerative medicine technique. Future phase III trials should be conducted to validate these findings and lead to potential label claims granted by the FDA.
If you or someone you know has interest in regenerative medicine for plantar fasciitis, make an appointment to see Dr. Ashraf Hanna at the Florida Regenerative Institute. Dr. Hanna employs the latest regenerative medicine techniques and his patients have experienced drastic improvements in pain and functional endpoints.