Shawn Cazzell1, Jordan Stewart2, Patrick S Agnew3, John Senatore4, Jodi Walters5, Douglas Murdoch6, Alex Reyzelman7, Stuart D Miller8. 1. 1 Limb Preservation Platform, Inc, Fresno, CA, USA. 2. 2 Timonium Foot & Ankle Center, Timonium, MD, USA. 3. 3 Coastal Podiatry Center, Virginia Beach, VA, USA. 4. 4 Union Memorial Hospital, Baltimore, MD, USA. 5. 5 Southern Arizona VA Health Care System, Tuscon, AZ, USA. 6. 6 Baylor / Scott & White Podiatry Center, Temple, TX, USA. 7. 7 Center for Clinical Research, Inc, Castro Valley, CA, USA. 8. 8 MedStar Union Memorial Hospital, Baltimore, MD, USA.
Abstract
BACKGROUND: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. METHODS: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. 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. RESULTS: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. CONCLUSION:Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. LEVEL OF EVIDENCE: Level I, prospective randomized trial.
RCT Entities:
BACKGROUND: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. METHODS: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. 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. RESULTS: 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. CONCLUSION:Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. LEVEL OF EVIDENCE: Level I, prospective randomized trial.
Entities:
Keywords:
chronic pain; dehydrated human amnion/chorion membrane; plantar fasciitis
Authors: Sara Heintzman Galli; Chad M Ferguson; W Hodges Davis; Robert Anderson; Bruce E Cohen; Carroll P Jones; Susan Odum; J Kent Ellington Journal: Foot Ankle Orthop Date: 2021-01-25