COMPLETED

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

Conditions

Diabetic Foot Ulcer Diabetic Wound Diabetic Foot Foot Ulcer Exosome Extracellular Vesicle

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

Official Title

A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

Quick Facts

Study Start:2024-02-27

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06319287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males and females ≥ 18 years of age 2. Properly obtained written informed consent 3. Documented history of Type I or Type II Diabetes Mellitus, requiring oral and/or insulin replacement therapy 4. The index ulcer is classified as Wagner grade 1 ulcer and remains Wagner 1 Grade between Screening and Randomization/Baseline visit (Visit 1 through Visit 3) 5. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutaneous tissue 6. Area of index ulcer must be between 1 cm2 to 15 cm2 post debridement at screening and baseline 7. The index ulcer must be located anatomically on the foot with ≥ 50% of the wound area below the medial or lateral malleolus 8. Presence of a persistent nonhealing DFU for at least 4 weeks from Randomization and not more than 1 year that has failed to respond to SOC at any point during this timeframe 9. Adequate vascular perfusion as evidenced by one of the following: 1. Dorsal transcutaneous oxygen measurement (TCOM/TcPO2) measurement of 2. Ankle Branchial Index (ABI) between 0.7 and 1.3 within 90 days of Screening (Visit 1 or 2) using the extremity on which the index ulcer is located 3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and/or posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable within 90 days of Screening (Visit 1 or 2) 10. The index ulcer has been offloaded with protocol defined offloading device during Screening (Run-In) period through Randomization/Baseline visit. 11. Must meet one of the following criteria: 12. Ability to comply with the study protocol as per investigator discretion	1. Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the DFU wound site and in remission based on scans, bloodwork or some other kind of test, such as a breast biopsy or a bone marrow biopsy) 2. Ulceration with exposed tendon, capsule, or bone 3. Suspicion of bone or joint infection by clinical or other criteria as per STONEES criteria below: 4. Unable or unwilling to utilize the protocol defined offloading device 5. Subjects who have undergone endovascular or open revascularization of the index limb within the last 30 days from Screening. 6. Index ulcer has decreased in area by ≥ 30% between Screening (Visit 1) and Baseline visits 7. Any subject that is currently on/or requires oral, systemic or topical antibiotics, or is anticipated to require their use during the course of the study 8. Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation 9. Serum Creatinine level \> 3.0 mg/dL 10. Hemoglobin A1c (HbA1c) \>12% 11. Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) \>3x the upper limit of normal 12. Acute active Charcot foot 13. The location of the index ulcer is within 2 cm of any other ulcer 14. Any subject that would be unable to safely monitor the infection status of the index ulcer at home and return for scheduled visits 15. History of immunosuppression or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions for up to 5 days 16. Any subject with a life expectancy ≤ 6 months 17. Pregnancy, including a positive pregnancy test at Baseline, or lactation/breastfeeding at anytime 18. Use of investigational drugs or biologics within 28 days prior to screening (Visit 1 or 2) 19. History of a concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol 20. Known or suspected active abuse of alcohol, or non-prescription drugs 21. Participation in another interventional clinical study or study in the past 30 days of Screening (Visit 1 or 2) or concurrent participation in another interventional clinical study 22. Subjects who have untreated Hep C 23. Subjects who are HIV positive 24. Subjects on anticoagulation that are not maintained within the International Normalized Ratio (INR) of \> 3.0

Inclusion Criteria

Exclusion Criteria

1. Males and females ≥ 18 years of age
2. Properly obtained written informed consent
3. Documented history of Type I or Type II Diabetes Mellitus, requiring oral and/or insulin replacement therapy
4. The index ulcer is classified as Wagner grade 1 ulcer and remains Wagner 1 Grade between Screening and Randomization/Baseline visit (Visit 1 through Visit 3)
5. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutaneous tissue
6. Area of index ulcer must be between 1 cm2 to 15 cm2 post debridement at screening and baseline
7. The index ulcer must be located anatomically on the foot with ≥ 50% of the wound area below the medial or lateral malleolus
8. Presence of a persistent nonhealing DFU for at least 4 weeks from Randomization and not more than 1 year that has failed to respond to SOC at any point during this timeframe
9. Adequate vascular perfusion as evidenced by one of the following:
1. Dorsal transcutaneous oxygen measurement (TCOM/TcPO2) measurement of
2. Ankle Branchial Index (ABI) between 0.7 and 1.3 within 90 days of Screening (Visit 1 or 2) using the extremity on which the index ulcer is located
3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and/or posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable within 90 days of Screening (Visit 1 or 2)
10. The index ulcer has been offloaded with protocol defined offloading device during Screening (Run-In) period through Randomization/Baseline visit.
11. Must meet one of the following criteria:
12. Ability to comply with the study protocol as per investigator discretion

1. Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the DFU wound site and in remission based on scans, bloodwork or some other kind of test, such as a breast biopsy or a bone marrow biopsy)
2. Ulceration with exposed tendon, capsule, or bone
3. Suspicion of bone or joint infection by clinical or other criteria as per STONEES criteria below:
4. Unable or unwilling to utilize the protocol defined offloading device
5. Subjects who have undergone endovascular or open revascularization of the index limb within the last 30 days from Screening.
6. Index ulcer has decreased in area by ≥ 30% between Screening (Visit 1) and Baseline visits
7. Any subject that is currently on/or requires oral, systemic or topical antibiotics, or is anticipated to require their use during the course of the study
8. Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation
9. Serum Creatinine level \> 3.0 mg/dL
10. Hemoglobin A1c (HbA1c) \>12%
11. Aspartate Aminotransferase (AST, GOT) and/or Alanine Aminotransferase (ALT, GPT) \>3x the upper limit of normal
12. Acute active Charcot foot
13. The location of the index ulcer is within 2 cm of any other ulcer
14. Any subject that would be unable to safely monitor the infection status of the index ulcer at home and return for scheduled visits
15. History of immunosuppression or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg/day or less for chronic conditions for up to 5 days
16. Any subject with a life expectancy ≤ 6 months
17. Pregnancy, including a positive pregnancy test at Baseline, or lactation/breastfeeding at anytime
18. Use of investigational drugs or biologics within 28 days prior to screening (Visit 1 or 2)
19. History of a concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
20. Known or suspected active abuse of alcohol, or non-prescription drugs
21. Participation in another interventional clinical study or study in the past 30 days of Screening (Visit 1 or 2) or concurrent participation in another interventional clinical study
22. Subjects who have untreated Hep C
23. Subjects who are HIV positive
24. Subjects on anticoagulation that are not maintained within the International Normalized Ratio (INR) of \> 3.0

Contacts and Locations

Study Locations (Sites)

Professional Education & Research Institute (PERI)

Blue Ash, Ohio, 45242

United States

Collaborators and Investigators

Sponsor: Rion Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2024-02-27

Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

Diabetic Foot Ulcer
Diabetic Wound
Diabetic Foot
Foot Ulcer
Exosome
Extracellular Vesicle

Additional Relevant MeSH Terms

Diabetic Foot Ulcer