COMPLETED

Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Conditions

Diabetic Foot Diabetic Foot Ulcer Foot Ulcer Chronic Foot Ulcer Extracellular matrix Regenerative medicine Leg ulcer Diabetes Mellitus Diabetic Angiopathies Diabetes Complications

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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

The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Official Title

A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers

Quick Facts

Study Start:2023-06-08

Study Completion:2025-11-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06035536

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\. At least 18 years old, inclusive. * 2\. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix B 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 TV1. * 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.	* 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 * 15\. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Inclusion Criteria

Exclusion Criteria

* 1\. At least 18 years old, inclusive.
* 2\. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix B 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 TV1.
* 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.

* 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
* 15\. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit

Contacts and Locations

Principal Investigator

David Armstrong, DPM, MD PhD

STUDY_CHAIR

Keck School of Medicine

Study Locations (Sites)

LA Foot and Ankle

Los Angeles, California, 90010

United States

Clemente Clinical Research Inc.

Los Angeles, California, 90033

United States

Bay Area Foot Care

San Francisco, California, 94115

United States

Doctor's Research Network

Miami, Florida, 33143

United States

Barry University Clinical Research

Tamarac, Florida, 33321

United States

Curalta Foot and Ankle

Westwood, New Jersey, 07675

United States

Foot and Ankle Specialists of the Mid-Atlantic

Gastonia, North Carolina, 28054

United States

Lower Extremity Institute for Research and Therapy

Boardman, Ohio, 44512

United States

Martin Foot and Ankle

York, Pennsylvania, 17402

United States

Perfizien Clinical Research

Houston, Texas, 77055

United States

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153

United States

Collaborators and Investigators

Sponsor: Aroa Biosurgery Limited

David Armstrong, DPM, MD PhD, STUDY_CHAIR, Keck School of Medicine

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 Date2023-06-08

Study Completion Date2025-11-03

Study Record Updates

Study Start Date2023-06-08

Study Completion Date2025-11-03

Terms related to this study

Keywords Provided by Researchers

Extracellular matrix
Regenerative medicine
Leg ulcer
Diabetes Mellitus
Diabetic Angiopathies
Diabetes Complications

Additional Relevant MeSH Terms

Diabetic Foot
Diabetic Foot Ulcer
Foot Ulcer
Chronic Foot Ulcer