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Regenerative Medicine

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Phase 3
Waitlist Available
Led By Stuart D Miller, MD
Research Sponsored by MiMedx Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
Pivotal Trial

Summary

Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Eligible Conditions
  • Plantar Fasciitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in VAS score
Incidence of adverse events
Secondary study objectives
Foot Function Index - Revised (FFI-R) (Short Form)

Side effects data

From 2022 Phase 2 trial • 447 Patients • NCT03485157
22%
Arthralgia
5%
Osteoarthritis
4%
Back pain
3%
Joint swelling
3%
Pain in extremity
2%
Joint effusion
2%
Fall
2%
Muscle strain
2%
Upper respiratory tract infection
1%
Headache
1%
Joint noise
1%
Rotator cuff syndrome
1%
Synovial cyst
1%
Intervertebral disc degeneration
1%
Muscle spasms
1%
Neck pain
1%
Plantar fasciitis
1%
Injection site joint pain
1%
Oedema peripheral
1%
Injection site pain
1%
Pain
1%
Ligament sprain
1%
Joint injury
1%
Rib fracture
1%
Limb injury
1%
Tendon rupture
1%
Sinusitis
1%
Urinary tract infection
1%
Sciatica
1%
Inguinal hernia
1%
Nausea
1%
Pruritus
1%
Cataract
1%
SARS-CoV-2 test positive
1%
Cardiac failure congestive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Saline
Micronized dHACM
Open-Label Micronized dHACM

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Micronized dHACMExperimental Treatment1 Intervention
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
Group II: Saline InjectionPlacebo Group1 Intervention
Injection of 1mL 0.9% Sodium Chloride Injection, USP

Find a Location

Who is running the clinical trial?

MiMedx Group, Inc.Lead Sponsor
35 Previous Clinical Trials
2,621 Total Patients Enrolled
Stuart D Miller, MDPrincipal InvestigatorMedStar Union Memorial Hospital, Baltimore, MD
2 Previous Clinical Trials
293 Total Patients Enrolled
~26 spots leftby Jan 2026
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