A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's
Public ClinicalTrials.gov record NCT05193929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05193929
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2021 (Actual)
- Primary completion
- Dec 1, 2025 (Actual)
- Completion
- Dec 1, 2025 (Actual)
- Last update posted
- Mar 19, 2026
2021 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Titan Clinical Research | Phoenix | Arizona | 85004 | — |
| Felix Sigal | Los Angeles | California | 90010 | — |
| Clemente Clinical Research | Los Angeles | California | 90033 | — |
| ILD Research | Vista | California | 92083 | — |
| Midland Florida clinical Research Center LLC | DeLand | Florida | 32720 | — |
| Integral Clinical Trial Solutions | Homestead | Florida | 33030 | — |
| Integral Clinical Trials Solutions | Pembroke Pines | Florida | 33026 | — |
| Integral Clinical Trials Solutions | Tamarac | Florida | 33321 | — |
| Viable Research Management | Las Vegas | Nevada | 89120 | — |
| Foot Associates of New York | New York | New York | 10022 | — |
| Foot & Ankle specialists of the Mid-Atlantic | Gastonia | North Carolina | 28054 | — |
| Foot & Ankle Specialists of the Mid-Atlantic | Raleigh | North Carolina | 27609 | — |
| Lower Extremity Institution of Research and Therapy (LEIRT) | Boardman | Ohio | 44512 | — |
| Mt. Olympus Medical Research | Houston | Texas | 77054 | — |
| Clinical Trials Network | Houston | Texas | 77074 | — |
| Foot and Ankle Specialist of the Mid-Atlantic - Roanoke | Roanoke | Virginia | 24016 | — |
| Foot and Ankle Specialist of the Mid-Atlantic - Salem | Salem | Virginia | 24153 | — |
| Salem Research institute | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05193929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05193929 live on ClinicalTrials.gov.