A Clinical Investigation Evaluating Wound Closure with OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

August 1, 2025

Study Completion Date

December 1, 2025

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

OptiPulse™

TheOptiPulse™ is designed to enhance blood circulation in the venules and arterioles in subjects with diabetic foot ulcers of the lower extremities. OptiPulse™ is supplied as a pair of footwear. One side is fitted with an off loader and shin pumping unit, and the other acts as pressure reducing footwear.Both active and non-active footwear should be worn to give balanced gait

DEVICE

Standard of Care offloading device

CAM boot

Trial Locations (19)

10022

RECRUITING

Foot Associates of New York, New York

24016

RECRUITING

Foot and Ankle Specialist of the Mid-Atlantic - Roanoke, Roanoke

24153

RECRUITING

Foot and Ankle Specialist of the Mid-Atlantic - Salem, Salem

RECRUITING

Salem Research institute, Salem

27609

RECRUITING

Foot & Ankle Specialists of the Mid-Atlantic, Raleigh

28054

RECRUITING

Foot & Ankle specialists of the Mid-Atlantic, Gastonia

32720

RECRUITING

Midland Florida clinical Research Center LLC, DeLand

33026

RECRUITING

Integral Clinical Trials Solutions, Pembroke Pines

33030

RECRUITING

Integral Clinical Trial Solutions, Homestead

33321

RECRUITING

Integral Clinical Trials Solutions, Tamarac

44512

RECRUITING

Lower Extremity Institution of Research and Therapy (LEIRT), Boardman

77054

RECRUITING

Mt. Olympus Medical Research, Houston

77074

RECRUITING

Clinical Trials Network, Houston

85004

RECRUITING

Titan Clinical Research, Phoenix

89120

RECRUITING

Viable Research Management, Las Vegas

90010

RECRUITING

Felix Sigal, Los Angeles

90033

RECRUITING

Clemente Clinical Research, Los Angeles

92083

RECRUITING

ILD Research, Vista

Unknown

RECRUITING

East Toronto Vascular Clinic, Toronto

All Listed Sponsors
collaborator

Professional Education and Research Institute

OTHER

lead

Compedica Inc

INDUSTRY

NCT05193929 - A Clinical Investigation Evaluating Wound Closure with OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's | Biotech Hunter | Biotech Hunter