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Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

Primary Purpose

Wound Healing, Diabetic Foot, Chronic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoform™ Antibacterial
Endoform™ Natural
Symphony™
Sponsored by
Aroa Biosurgery Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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 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

Sites / Locations

  • South Florida Lower Extremity CenterRecruiting
  • Foot and Ankle Specialists of the Mid-AtlanticRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer

Arm Description

Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading

Outcomes

Primary Outcome Measures

Percentage of index ulcers (the ulcers being treated in the study) 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 ulcers 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). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Change in subjects reported pain levels (NPRS)
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".

Full Information

First Posted
August 23, 2023
Last Updated
September 13, 2023
Sponsor
Aroa Biosurgery Limited
Collaborators
Professional Education and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06035523
Brief Title
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 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
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.
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
Arm Type
Other
Arm Description
Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading
Intervention Type
Device
Intervention Name(s)
Endoform™ Antibacterial
Intervention Description
Application of Endoform™ Antibacterial
Intervention Type
Device
Intervention Name(s)
Endoform™ Natural
Intervention Description
Application of Endoform™ Natural
Intervention Type
Device
Intervention Name(s)
Symphony™
Intervention Description
Application of Symphony™
Primary Outcome Measure Information:
Title
Percentage of index ulcers (the ulcers being treated in the study) 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 ulcers 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). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
Time Frame
12 weeks
Title
Change in subjects reported pain levels (NPRS)
Description
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".
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Product wastage
Description
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
Time Frame
12 weeks
Title
Cost to closure
Description
Calculation of cost of treatment, including number of device applications for each treatment group
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 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
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, DMP
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
South Florida Lower Extremity Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Taylor
Phone
954-278-3890
Ext
3
Email
ksteph8624@gmail.com
First Name & Middle Initial & Last Name & Degree
Nooshin Zolfaghari, DPM
Facility Name
Foot and Ankle Specialists of the Mid-Atlantic
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie Guilliams
Phone
540-395-3107
Email
kguilliams@footandankle-usa.com
First Name & Middle Initial & Last Name & Degree
Ivan Rubiano, DPM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

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