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Evaluating OptiPulse™ for treating diabetic foot ulcers

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

Not applicable Interventional Compedica Inc · NCT05193929

This study is testing if the OptiPulse™ device can help heal diabetic foot ulcers better than the usual treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorCompedica Inc Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations19 sites (Phoenix, Arizona and 18 other locations)
Trial IDNCT05193929 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the safety and effectiveness of Compedica's OptiPulse™ device in treating diabetic foot ulcers (DFUs) compared to standard care. The OptiPulse™ is designed to improve blood circulation in the affected areas, while a collagen alginate dressing is used as the primary dressing. Participants will have their outcomes monitored to determine the performance of this new approach against traditional methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a Wagner Grade 1 diabetic foot ulcer that has persisted for more than 4 weeks.

Not a fit: Patients with ulcers that are not classified as Wagner Grade 1 or those with inadequate circulation to the affected foot may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers.

How similar studies have performed: While this approach is innovative, similar studies evaluating advanced wound care technologies have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Foot Ulcer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.