Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

• ClinicalTrials.gov Identifier: NCT06035523
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: September 15, 2023
• Sponsor: Aroa Biosurgery Limited
• Collaborator: Professional Education and Research Institute
• Information provided by (Responsible Party): Aroa Biosurgery Limited

Study Description

Brief Summary:

Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.

Condition or disease	Intervention/treatment	Phase
Wound Healing; Diabetic Foot; Chronic Foot Ulcer; Foot Ulcer	Device: Endoform™ Antibacterial; Device: Endoform™ Natural; Device: Symphony™	Not Applicable

Detailed Description:

About 50 subjects will take part in this study. The purpose of this study is to evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds, including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.

Following initial enrollment, eligible subjects will then undergo

• a treatment phase involving weekly treatment and evaluations for up to 12 weeks,
• subjects that heal will enter a follow-up period that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing.
• If the subject does not heal, they will exit at Week 13, End of Study visit.

All subjects will require accepted routine procedures as part of standard of care (SOC): offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's foot is too large for a removeable cast boot), appropriate sharp debridement, and infection management. In addition, each subject will receive a wound care covering comprising of either Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers
• Actual Study Start Date: December 29, 2021
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer; Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading	Device: Endoform™ Antibacterial; Application of Endoform™ Antibacterial; Device: Endoform™ Natural; Application of Endoform™ Natural; Device: Symphony™; Application of Symphony™

Outcome Measures

Primary Outcome Measures :

1. Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks [ Time Frame: 12 weeks ]
   Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks

Secondary Outcome Measures :

1. Time to heal within 12 weeks [ Time Frame: 12 weeks ]
   Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
2. Percentage area reduction at 12 weeks [ Time Frame: 12 weeks ]
   Area reduction percentage of ulcers at 12 weeks
3. Changes in wound quality of life (per W-QoL) [ Time Frame: 12 weeks ]
   Changes in wound quality of life (W-QoL), using the W-QoL short questionnaire administered on Study Visit 1 (as a baseline) and after 12 weeks of treatment (End of Study Visit). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
4. Change in subjects reported pain levels (NPRS) [ Time Frame: 12 weeks ]
   Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study Visit).On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".

Other Outcome Measures:

1. Product wastage [ Time Frame: 12 weeks ]

   For each product, the size actually used will be the basis to calculate the area of the product.

   Based on the investigator's notes, wound area at time of application will be calculated as a rectangle (length x width) reduced to an ellipsoid.

   Wastage = ((area of product - area of wound)/area of product)*100

2. Cost to closure [ Time Frame: 12 weeks ]
   Calculation of cost of treatment, including number of device applications for each treatment group

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 1. At least 18 years old, inclusive.
• 2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix D for definitions), extending through the dermis provided it is below the medial aspect of the malleolus.
• 3. The index ulcer (ulcer to be evaluated in the study) 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 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 1.0 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 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 SV1.
• 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 xray 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 enrollment
• 14. Presence of acute Charcot Neuroarthropathy to the affected limb

Contacts and Locations

Contacts

Contact: Shelby Caylor; 513-815-8160; scaylor@periedu.com

Contact: Frances Parker, DMP; 540-581-6915; fparker@peredu.com

Locations

United States, Florida

South Florida Lower Extremity Center; Recruiting

Hollywood, Florida, United States, 33312

Contact: Karla Taylor 954-278-3890 ext 3 ksteph8624@gmail.com

Principal Investigator: Nooshin Zolfaghari, DPM

United States, Virginia

Foot and Ankle Specialists of the Mid-Atlantic; Recruiting

Salem, Virginia, United States, 24153

Contact: Kristie Guilliams 540-395-3107 kguilliams@footandankle-usa.com

Principal Investigator: Ivan Rubiano, DPM

Sponsors and Collaborators

Aroa Biosurgery Limited

Professional Education and Research Institute

Investigators

• Study Chair: David Armstrong, DPM, MD PhD; Keck School of Medicine

More Information

• Responsible Party: Aroa Biosurgery Limited
• ClinicalTrials.gov Identifier: NCT06035523
• Other Study ID Numbers: AROA 002
• First Posted: September 13, 2023
• Last Update Posted: September 15, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Aroa Biosurgery Limited:

Extracellular matrix; Regenerative medicine; Leg ulcer; Diabetes complications; Diabetic Angiopathies; Diabetes Mellitus

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Anti-Bacterial Agents; Anti-Infective Agents