Modified Platform Trial Assessing Multiple CAMPs and SOC Vs SOC Alone in the Treatment of Hard-to-Heal DFUs

NARecruitingINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

July 16, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

August 31, 2026

Conditions
Diabetic Foot Ulcer (DFU)Ulcer FootDiabetic FootFoot Ulcer
Interventions
OTHER

Standard of Care

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Revita

Participants will receive weekly applications of Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Relese

Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Cogenex

Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Enverse

Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Trial Locations (5)

15025

NOT_YET_RECRUITING

SerenaGroup Research South, Jefferson Hills

15146

RECRUITING

SerenaGroup Monroeville, Monroeville

16201

NOT_YET_RECRUITING

Armstrong County Memorial Hospital, Kittanning

68114

RECRUITING

SerenaGroup Omaha Research Center, Omaha

74135

RECRUITING

Wound Care of Tulsa, Tulsa

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

StimLabs

INDUSTRY