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An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

NCT03723603 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-03-18

Study results available
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Summary

Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.

Conditions

  • Wound

Interventions

DEVICE

Fibrillar collagen powder dressing

A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.

Sponsors & Collaborators

  • Medline Industries

    lead INDUSTRY

Principal Investigators

  • Windy Cole · Cleveland Foot and Ankle Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2019-06-04
Completion
2019-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723603 on ClinicalTrials.gov