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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronized Amniotic Membrane | Experimental | Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl |
|
| Preservative Free Normal Saline | Placebo Comparator | 2.0 mL sterile, preservative free 0.9% NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flo | Other | sterile, micronized human amniotic membrane product derived from placenta and umbilical cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Achilles pain | A score of 0 is considered no pain while a score of 10 is considered very severe pain | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in NRS score | A score of 0 is considered no pain while a score of 10 is considered very severe pain | over 3 months |
| Change from Baseline in VISA-A score | over 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Park Podiatry | San Diego | California | 92104 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Other | sterile, preservative free 0.9% NaCl |
|
| Proportion of responders based on change in VISA-A score | 20 points as a threshold for assignment of responder status | over 3 months |
| Proportion of complete pain relief | pain score of 0 | over 3 months |
| Time to complete pain relief | pain score of 0 | over 3 months |
| Proportion of subjects that respond feeling at least better and satisfied | patient satisfaction survey | 3 months |
| D017670 |
| Sodium Compounds |