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NCT04437537 · ClinicalTrials.gov registry record · NA

Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome

A NA study of Diabetic Foot Ulcer, sponsored by RenovoDerm.

Completed
Registry status
NA
Development phase
11
Enrollment target
1
Study location

NCT04437537: Completed NA study of Diabetic Foot Ulcer, sponsored by RenovoDerm.

NCT04437537 is a NA study of Diabetic Foot Ulcer that has completed, run by RenovoDerm. The registered enrollment target is 11 participants, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04437537, a NA study of Diabetic Foot Ulcer, has completed, sponsored by RenovoDerm.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers

Primary Outcome

Analysis of the wound microbiome in subjects with chronic DFUs prior to PHOENIX application and at follow-up Study Visits 3, and possibly 5 (if debridement is deemed necessary by the Investigator), again prior to the application of PHOENIX. This analysis will identify and quantify bacterial and fungal microorganisms present in the wound bed.

Conditions Studied

Interventions

  • DEVICE Bioresorbable 3D electrospun synthetic matrix

Study Locations (1)

Pennsylvania

  • PA Foot & Ankle Associates - Northampton

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2025-03-21
Est. Completion 2025-07-21
Phase NA
RenovoDerm

1 total trials

What the finished NCT04437537 record still lists

NCT04437537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Bioresorbable 3D electrospun synthetic matrix is the first listed.

NCT04437537 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04437537 about?

NCT04437537 is a clinical study titled "Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome". A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers

What is the current status of trial NCT04437537?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2025-03-21. Estimated completion is 2025-07-21.

What conditions does trial NCT04437537 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcer.

What interventions are being tested in trial NCT04437537?

The interventions under investigation include: Bioresorbable 3D electrospun synthetic matrix (DEVICE).

Who is sponsoring clinical trial NCT04437537?

This trial is sponsored by RenovoDerm, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04437537 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetic Foot Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04437537's enrollment target sits among peer trials

11 66th of 67 higher than 2 of 67 other Diabetic Foot Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Foot Ulcer 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 NCT04437537, the US trial registry maintained by the National Library of Medicine. NCT04437537 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.