NCT06035523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 28, 2026

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

August 23, 2023

Last Update Submit

January 26, 2026

Conditions

Wound HealingDiabetic FootChronic Foot UlcerFoot Ulcer

Keywords

Extracellular matrixRegenerative medicineLeg ulcerDiabetes complicationsDiabetic AngiopathiesDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (4)

  • Time to heal within 12 weeks

    12 weeks

  • Percentage area reduction at 12 weeks

    12 weeks

  • Changes in wound quality of life (per W-QoL)

    12 weeks

  • Change in subjects reported pain levels (NPRS)

    12 weeks

Other Outcomes (2)

  • Product wastage

    12 weeks

  • Cost to closure

    12 weeks

Study Arms (1)

Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer

OTHER

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

Device: Endoform™ AntibacterialDevice: Endoform™ NaturalDevice: Symphony™

Interventions

Endoform™ AntibacterialDEVICE

Application of Endoform™ Antibacterial

Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
Endoform™ NaturalDEVICE

Application of Endoform™ Natural

Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
Symphony™DEVICE

Application of Symphony™

Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. At least 18 years old, inclusive.
  • \. 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.
  • \. 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.
  • \. 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.
  • \. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
  • \. 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.
  • \. The target ulcer has been offloaded for at least 14 days, prior to SV1.
  • \. 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.
  • \. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
  • \. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.

You may not qualify if:

  • \. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
  • \. 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.
  • \. Index ulcer is overtly infected (i.e., purulent drainage).
  • \. 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.
  • \. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
  • \. History of radiation at the ulcer site (regardless of time since last radiation treatment).
  • \. Index ulcer has been previously treated or will need to be treated with any prohibited therapies.
  • \. Subjects with a previous diagnosis of HIV or Hepatitis C.
  • \. 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.
  • \. 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).
  • \. Subject is pregnant or breast-feeding.
  • \. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days.
  • \. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
  • \. Presence of acute Charcot Neuroarthropathy to the affected limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

South Florida Lower Extremity Center

Hollywood, Florida, 33312, United States

Location

Advanced Pharma Cr, LLC

Miami, Florida, 33147, United States

Location

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-1100, United States

Location

MeSH Terms

Conditions

Diabetic FootFoot UlcerLeg UlcerDiabetes ComplicationsDiabetic AngiopathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesDiabetic NeuropathiesFoot DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Armstrong, DPM, MD PhD

    Keck School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 13, 2023

Study Start

December 29, 2021

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

January 28, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)