search
Back to results

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

Primary Purpose

Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symphony™ plus Off-loading
Wound Dressing comprising of calcium alginate Fibracol
Sponsored by
Aroa Biosurgery Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes Mellitus, Diabetic Angiopathies, Diabetes Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LA Foot and AnkleRecruiting
  • Bay Area Foot CareRecruiting
  • Doctor's Research NetworkRecruiting
  • Barry University Clinical ResearchRecruiting
  • Foot and Ankle Specialists of the Mid-AtlanticRecruiting
  • Lower Extremity Institute for Research and TherapyRecruiting
  • Martin Foot and AnkleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Symphony™ treatment

Standard of Care (SOC) treatment

Arm Description

Arm receives an application of Symphony™ treatment and appropriate Off-loading.

Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.

Outcomes

Primary Outcome Measures

Percentage of index ulcers healed at 12 weeks
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks

Secondary Outcome Measures

Time to heal within 12 weeks
Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
Percentage area reduction at 12 weeks
Area reduction percentage of ulcer at 12 weeks
Changes in wound quality of life (per W-QoL)
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) normalized to a single value. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Change in pain levels during the clinical investigation
Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at each weekly visit. On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".

Full Information

First Posted
August 23, 2023
Last Updated
September 25, 2023
Sponsor
Aroa Biosurgery Limited
Collaborators
Professional Education and Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT06035536
Brief Title
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aroa Biosurgery Limited
Collaborators
Professional Education and Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the time of completion of screening to either Symphony™ treatment or Standard of Care (SOC) treatment groups. Following initial enrolment, eligible subjects will then undergo: A screening phase consisting of 14 days to determine eligibility. Eligible subjects will then undergo a treatment phase involving weekly treatment and evaluations for up to 12 weeks. Subjects that heal will undergo a follow-up phase 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. Both treatment groups will receive accepted routine procedures being part of SOC, including offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject's foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and infection management. In addition to what is noted above, Group 1 will receive a weekly application of Symphony™ and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups will have 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 3layer or equivalent) applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
Keywords
Extracellular matrix, Regenerative medicine, Leg ulcer, Diabetes Mellitus, Diabetic Angiopathies, Diabetes Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symphony™ treatment
Arm Type
Experimental
Arm Description
Arm receives an application of Symphony™ treatment and appropriate Off-loading.
Arm Title
Standard of Care (SOC) treatment
Arm Type
Active Comparator
Arm Description
Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.
Intervention Type
Device
Intervention Name(s)
Symphony™ plus Off-loading
Intervention Description
Application of Symphony™
Intervention Type
Device
Intervention Name(s)
Wound Dressing comprising of calcium alginate Fibracol
Intervention Description
Application of Wound Dressing comprising of calcium alginate Fibracol.
Primary Outcome Measure Information:
Title
Percentage of index ulcers healed at 12 weeks
Description
Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to heal within 12 weeks
Description
Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
Time Frame
12 weeks
Title
Percentage area reduction at 12 weeks
Description
Area reduction percentage of ulcer at 12 weeks
Time Frame
12 weeks
Title
Changes in wound quality of life (per W-QoL)
Description
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) normalized to a single value. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Time Frame
after 12 weeks
Title
Change in pain levels during the clinical investigation
Description
Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at each weekly visit. On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Product wastage (Symphony only)
Description
Product wastage (applies only to DFUs treated with Symphony). Area of Symphony device; wound area at time of application based on digital planimetry imaging of area. Percentage wastage: (Area of DFU - area of Symphony/area of DFU) x 100.
Time Frame
12 weeks
Title
Cost to closure (both treatment groups; all wounds, and only closed wounds)
Description
Costs for all wounds per treatment group, and cost of healed wounds only per treatment group. Final values are cost per wound.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. 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 15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelby Caylor
Phone
513-815-8160
Email
scaylor@periedu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Parker
Phone
540-581-6915
Email
fparker@peredu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Armstrong, DPM, MD PhD
Organizational Affiliation
Keck School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
LA Foot and Ankle
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maira Jackson
Phone
213-365-0793
Email
maira@lafootpain.com
First Name & Middle Initial & Last Name & Degree
Felix Sigal, DPM
Facility Name
Bay Area Foot Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Peralta
Phone
800-363-1069
Ext
104
Email
maria@ccr-trials.com
First Name & Middle Initial & Last Name & Degree
Alex Reyzelman, DPM
Facility Name
Doctor's Research Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patria Division
Phone
305-665-3017
Email
pdivison@drnmiami.com
First Name & Middle Initial & Last Name & Degree
Jason Hanft
Facility Name
Barry University Clinical Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Swartz
Phone
305-836-7550
Email
MSwartz@barry.edu
First Name & Middle Initial & Last Name & Degree
Robert Snyder, DPM
Facility Name
Foot and Ankle Specialists of the Mid-Atlantic
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Jones
Phone
704-861-0425
Email
dvandyck@footandankle-usa.com
First Name & Middle Initial & Last Name & Degree
Ryan Meredith, DPM
Facility Name
Lower Extremity Institute for Research and Therapy
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica DiDomenico
Phone
234-719-7588
Email
jessica@leirt.com
First Name & Middle Initial & Last Name & Degree
Lawrence A DiDomenico, DPM
Facility Name
Martin Foot and Ankle
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Kasper, DPM
Phone
717-757-3537
Email
drmariakasper@yahoo.com
First Name & Middle Initial & Last Name & Degree
Renee Green
Phone
717-757-3537
Email
rgreen@martinfootandankle.com
First Name & Middle Initial & Last Name & Degree
Maria A Kasper, DPM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs