A Clinical Investigation Evaluating Wound Closure with OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's
NCT ID: NCT05193929
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-12-15
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OptiPulse™
The OptiPulse™ 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 offloaded 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.
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
Standard of care offloading device
Diabetic CAM boot
Standard of Care offloading device
CAM boot
Interventions
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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
Standard of Care offloading device
CAM boot
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Professional Education and Research Institute
OTHER
Compedica Inc
INDUSTRY
Responsible Party
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Locations
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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
Foot & Ankle specialists of the Mid-Atlantic
Gastonia, North Carolina, United States
Foot & Ankle Specialists of the Mid-Atlantic
Raleigh, North Carolina, United States
Lower Extremity Institution of Research and Therapy (LEIRT)
Boardman, Ohio, United States
Mt. Olympus Medical Research
Houston, Texas, United States
Clinical Trials Network
Houston, Texas, United States
Foot and Ankle Specialist of the Mid-Atlantic - Roanoke
Roanoke, Virginia, United States
Foot and Ankle Specialist of the Mid-Atlantic - Salem
Salem, Virginia, United States
Salem Research institute
Salem, Virginia, United States
East Toronto Vascular Clinic
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DBC-PUL-02
Identifier Type: -
Identifier Source: org_study_id
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