The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06035523
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
Professional Education and Research Institute
Information provided by (Responsible Party):
Aroa Biosurgery Limited

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).

Layout table for study information
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


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™




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035523


Contacts
Layout table for location contacts
Contact: Shelby Caylor 513-815-8160 scaylor@periedu.com
Contact: Frances Parker, DMP 540-581-6915 fparker@peredu.com

Locations
Layout table for location information
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         
Advanced Pharma Cr, LLC Recruiting
Miami, Florida, United States, 33147
Contact: Kimberly Cruz, MD    305-220-2727    kcruz@advancedpharmacr.com   
Principal Investigator: Kimberly Cruz, MD         
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         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431-1100
Contact: Mario Ponticello, DPM    253-968-4580    mario.n.ponticello.civ@health.mil   
Principal Investigator: Mario Ponticello, DPM         
Sponsors and Collaborators
Aroa Biosurgery Limited
Professional Education and Research Institute
Investigators
Layout table for investigator information
Study Chair: David Armstrong, DPM, MD PhD Keck School of Medicine
Layout table for additonal information
Responsible Party: Aroa Biosurgery Limited
ClinicalTrials.gov Identifier: NCT06035523    
Other Study ID Numbers: AROA 002
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for 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