Trials / Unknown
UnknownNCT06172218
AM for Refractory Achilles Tendinopathy
Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- North Park Podiatry · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate outcomes after use of micronized amniotic membrane to replace or supplement damaged or inadequate integumental tissue in patients with "chronic" insertional or non-insertional Achilles tendinopathy that remains refractory to standard care. Outcomes between a control and treatment group in this pilot study will be used to devise a multi-center study with larger sample size.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Flo | sterile, micronized human amniotic membrane product derived from placenta and umbilical cord |
| OTHER | Saline | sterile, preservative free 0.9% NaCl |
Timeline
- Start date
- 2023-11-22
- Primary completion
- 2024-04-28
- Completion
- 2024-06-28
- First posted
- 2023-12-15
- Last updated
- 2023-12-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06172218. Inclusion in this directory is not an endorsement.