CompletedPhase 3

Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

United States208 participantsStarted 2018-01-08

Plain-language 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

Who can participate

Age range

21 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Confirmed diagnosis of plantar fasciitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator
. VAS Pain scale of ≥ 45 mm at randomization
. Plantar fasciitis with conservative treatment for ≥ 1 month (30 days), including any of the following modalities:
. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities
. BMI ≤ 40 kg/m2
. Age ≥ 21 years and \< 80 years
. Ability to sign Informed Consent and Release of Medical Information Forms
. Ability to receive and respond to text messages or emails on a daily basis.

Exclusion criteria

. Prior surgery or trauma to the affected site
. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment
. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in VAS score

Timeframe: 90 Days

Incidence of adverse events

Timeframe: 180 Days

Trial details

NCT IDNCT03414268

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-17

View on ClinicalTrials.gov More Fasciitis, Plantar trials