NCT05796765Phase 2Terminated

Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis

Study sponsor: MiMedx Group, Inc. · MDXG

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-12-15Actual

Enrollment · participants43Actual

Source updated2024-01-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Knee Osteoarthritis

Treatments or interventions studied

Micronized DHACM 40 mgBiological
Micronized DHACM 100 mgBiological
SalineDrug

Primary outcomes · main study measures

Read the study measures

measure: Change in WOMAC pain subscale score between baseline and Day 180; description: Efficacy Endpoint; timeFrame: 180 days; measure: Change in WOMAC function subscale score between baseline and Day 180; description: Efficacy Endpoint; timeFrame: 180 days; measure: Proportions of subjects who report treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); description: Safety Endpoint; timeFrame: 365 days

History coverage

Imported research includes version dates later than the current official API record (2024-01-17). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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