MedTrace Logo

DermACELL in Subjects With Chronic Wounds of the Lower Extremities

NCT01970163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2018-03-14

No results posted yet for this study

Summary

The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

DermACELL

Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).

OTHER

GraftJacket

Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).

OTHER

Conventional Care Dressings

Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing: * If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound. * Hydrogels can also be used if the wound is in need of moisture. * For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration. A secondary dressing may be desired to add either loft or cushion.

Sponsors & Collaborators

  • LifeNet Health

    lead INDUSTRY

Principal Investigators

  • Mark Moore, Ph.D. · LifeNet Health, Scientific Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-01-31
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01970163 on ClinicalTrials.gov