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

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 Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: OptiPulse™; Device: Standard of Care offloading device

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Blackman; Phone Number: +44 (0)7809144960; Email: Daniel.blackman@Compedica.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • East Toronto Vascular Clinic
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Titan Clinical Research
  • California
    • Los Angeles, California, United States, 90010
      • Recruiting
      • Felix Sigal
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Clemente Clinical Research
    • Vista, California, United States, 92083
      • Recruiting
      • ILD Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Midland Florida Clinical Research Center LLC
    • Homestead, Florida, United States, 33030
      • Recruiting
      • Integral Clinical Trial Solutions
    • Pembroke Pines, Florida, United States, 33026
      • Recruiting
      • Integral Clinical Trials Solutions
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • Integral Clinical Trials Solutions
  • Nevada
    • Las Vegas, Nevada, United States, 89120
      • Recruiting
      • Viable Research Management
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Foot Associates of New York
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • Recruiting
      • Foot & Ankle Specialists of the Mid-Atlantic
    • Raleigh, North Carolina, United States, 27609
      • Recruiting
      • Foot & Ankle Specialists of the Mid-Atlantic
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Recruiting
      • Lower Extremity Institution of Research and Therapy (LEIRT)
      • Contact: Diana Carpenter; Email: dcarpenter1125@gmail.com
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Mt. Olympus Medical Research
    • Houston, Texas, United States, 77074
      • Recruiting
      • Clinical Trials Network
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Foot and Ankle Specialist of the Mid-Atlantic - Roanoke
      • Contact: Kelly Johnson; Email: kjohnson2@footandankle-usa.com
    • Salem, Virginia, United States, 24153
      • Recruiting
      • Foot and Ankle Specialist of the Mid-Atlantic - Salem
      • Contact: Kristie Guilliams; Email: kguilliams@footandankle-usa.com
    • Salem, Virginia, United States, 24153
      • Recruiting
      • Salem Research institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Standard of care offloading device; Diabetic CAM boot	Device: Standard of Care offloading device; CAM boot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of index ulcers healed	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Ulcer Healing	12 weeks
Percentage Area Change	6 and 12 weeks
Changes in wound quality of life from screening visit to end of study ( per W-QoL)	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Cost to Closure	12 weeks

Collaborators and Investigators

• Sponsor: Compedica Inc
• Collaborators: Professional Education and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): September 11, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: DBC-PUL-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No