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A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's | Clinical Trials | Clareo Health

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

A Multi-center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

NCT05193929•Compedica Inc

View on ClinicalTrials.gov

Summary

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years old, inclusive.
•2. Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions) on the plantar or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.
•3. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
•4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
•5. Index ulcer is a minimum of 0.8 cm2 and a maximum of 25 cm2 at SV1 and TV1.
•6. Within 3 months of SV1, adequate circulation to the affected foot, as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
•7. The target ulcer has been offloaded for at least 14 days prior to randomization.
•8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
•9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
•10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

Exclusion Criteria

•1\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
•2\. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
•3\. Index ulcer is overtly infected (i.e. purulent drainage). 4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
•5\. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
•6\. History of radiation at the ulcer site (regardless of time since last radiation treatment).
•7\. Index ulcer has been previously treated or will need to be treated with any prohibited therapies.
•8\. Subjects with a previous diagnosis of HIV or Hepatitis C. 9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
•10\. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
•11\. Subject is pregnant or breast-feeding. 12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days.
•13\. Subjects with end-stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization. 14. Presence of active Charcot Neuroarthropathy to the affected limb. 15. Any wound located entirely on the medial or lateral border of the foot. 16. Any wound located between the 1st through 4th toe interspaces. 17. Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit.

Locations (19)

Titan Clinical Research

Phoenix, Arizona, United States

Felix Sigal

Los Angeles, California, United States

Clemente Clinical Research

Los Angeles, California, United States

ILD Research

Vista, California, United States

Midland Florida clinical Research Center LLC

DeLand, Florida, United States

Integral Clinical Trial Solutions

Homestead, Florida, United States

Integral Clinical Trials Solutions

Pembroke Pines, Florida, United States

Integral Clinical Trials Solutions

Tamarac, Florida, United States

Viable Research Management

Las Vegas, Nevada, United States

Foot Associates of New York

New York, New York, United States

Key Dates

Start Date

December 15, 2021

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 19, 2026

Enrollment

162

ACTUAL participants

Conditions

Diabetic Foot Ulcer

Interventions

OptiPulse™

DEVICE

Standard of Care offloading device

DEVICE

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

NCT07039396

Diabetic Foot Ulcer

View study

RECRUITINGPHASE1/PHASE2

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

NCT07396376

Diabetic Foot UlcerWagner Grade 1 - 2+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

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