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NCT02880592 · ClinicalTrials.gov registry record · NA

Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

A NA study, sponsored by Organogenesis.

Completed
Registry status
NA
Development phase
89
Enrollment target

NCT02880592: Completed NA study, sponsored by Organogenesis.

NCT02880592 is a NA study that has completed, run by Organogenesis. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02880592, a NA study, has completed, sponsored by Organogenesis.

COMPLETED
Registry status
NA
Development phase
89 participants
Enrollment target

Study Summary

This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.

Primary Outcome

Time to initial closure of diabetic foot ulcers will be compared between the two groups.

Interventions

  • OTHER Standard of care
  • OTHER Affinity Allograft

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2016-08
Est. Completion 2019-04-01
Phase NA
Organogenesis

20 total trials

What the finished NCT02880592 record still lists

NCT02880592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.

NCT02880592 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02880592 about?

NCT02880592 is a clinical study titled "Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers". This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.

What is the current status of trial NCT02880592?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2016-08. Estimated completion is 2019-04-01.

What interventions are being tested in trial NCT02880592?

The interventions under investigation include: Standard of care (OTHER), Affinity Allograft (OTHER).

Who is sponsoring clinical trial NCT02880592?

This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02880592's enrollment target sits among peer trials

89 972nd of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02880592, the US trial registry maintained by the National Library of Medicine. NCT02880592 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.