EDX110 Randomized Control Trial for Treatment of DFUs

NCT07209358 | Recruiting DMC FDA Device

• 1 other identifier: WC-24-447
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, multi-centered, observer blinded, pre-market study, 1:1 randomized control trial, to determine if addition of EDX110 dressing system to standard of care leads to an improvement in diabetic foot ulcers healing compared to just using standard of care.

Conditions

Wound Heal; Diabetic Foot Ulcer

Keywords

Hard to heal wounds

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  Incidence of complete wound closure at 16 weeks in participants with DFU who are receiving standard of care (SOC) versus participants receiving EDX110 and SOC. Wound closure is defined as 100% reepithelialization of the wound without drainage.

  16 Weeks

Secondary Outcomes (4)

• Time to Wound Closure

  16 Weeks

• Percent Area Reduction 4 weeks

  4 Weeks

• Percent Area Reduction 16 weeks

  16 weeks

• Wound closure at 24 weeks

  24 weeks

Other Outcomes (5)

• Hospitalizations relating to the target ulcer

  16 Weeks

• Amputations relating to the target ulcer

  16 Weeks

• Systemic antibiotic usage during the 16-week treatment period

  16 Weeks

Study Arms (2)

EDX110 with Standard of Care (SOC)

ACTIVE COMPARATOR

Diabetic Foot Ulcer (DFU) DFU treatment with EDX110 wound dressing and SOC

Device: EDX110

Standard of Care (SOC)

NO INTERVENTION

Diabetic Foot Ulcer (DFU) DFU treatment with using only traditional Standard of Care (SOC)

Interventions

EDX110 DEVICE

EDX110 wound dressing system EDX110 is a dressing system comprising two layers that allows the generation of nitric oxide (NO) in situ, enables adequate moisture management and facilitates debridement

EDX110 with Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study.
• The participant must have an index ulcer meeting the following characteristics:
• Non-healing DFU defined as; at least 4 weeks prior to enrolment the ulcer has failed to progress on a healing trajectory.
• Full-thickness wound; defined as Wagner Diabetic Foot Ulcer Grade 1 - superficial ulcer of skin or subcutaneous tissue.
• Located on the anatomical foot; defined as distal to the medial or lateral malleolus.
• Ulcer duration at randomization must be present for ≥1 month but less than \<24 months in duration.
• Post-debridement wound area is ≥0.1 cm2 and ≤25 cm2.
• If two or more ulcers either mono or bilateral are present, the index ulcer must additionally be:
• The ulcer with the largest wound area, as long as it meets all other criteria.
• ≥3cm distance from any other ulcer on the affected limb
• Known history of type 1 or type 2 diabetes (confirmed by the subject's medical history).
• HgbA1c \<12% (NGSP) OR 108 mmol/mol (IFCC) OR average blood glucose 298 mg/DL.
• Participant has adequate circulation to the affected extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grades 0-1 (no PAD to Mild PAD).
• Participants are required to have either.
• Ankle-Brachial Index (ABI) by Doppler: ≥0.6 OR Toe-Brachial Index (TBI) ≥ 0.5

You may not qualify if:

• Participants with wounds that have any of the following characteristics:
• Wagner Grade 2 - ulcers extend into tendon, bone, or capsule
• Grade 3 - deep ulcer with osteomyelitis, or abscess
• Grade 4 - partial foot gangrene
• Grade 5 - whole foot gangrene
• Infections that are classified as:
• PEDIS 3 (Moderate): Infection with no systemic manifestations and involving: Erythema extending ≥2 cm2 from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone).
• PEDIS 4 (Severe): All of the above in PEDIS 3 plus manifestations (of the systemic inflammatory response syndrome \[SIRS\]).
• In addition, any diabetic foot infections with; Confirmed underlying bone involvement (osteomyelitis) based on; imaging (plain X-ray, CT or MRI), clinical examination (exposed bone or positive probe to bone test) or culture/histopathology of a bone specimen
• OR Cellulitis/lymphangitis/soft tissue gas or necrotizing fasciitis originating from the wound site.
• Tunnelling, Cavity or undermining wounds.
• Known or suspected local skin malignancy at the site of the ulcer.
• A wound that is actively bleeding. This does not exclude enrollment once active bleeding has stopped (hemostasis).
• Gross Foot deformities that would interfere with proper off-loading or proper wound healing i.e. non-active charcot foot, rocker bottom foot, gross digital deformities.
• Active Charcot deformity.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (4)

Axentra Bio

Phoenix, Arizona, 85053, United States

RECRUITING

Clemente Clinical Research

Santa Ana, California, 92704, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

RECRUITING

Futuro Clinical Trials

McAllen, Texas, 78501, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Christina M Mastandrea, MS

  ConvaTec Inc.

  STUDY DIRECTOR

Central Study Contacts

Andrea M Picchietti

CONTACT

2604189196; andrea.picchietti@convatec.com

Christina Mastandrea

CONTACT

5088739580; christina.mastandrea@convatec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observer blinded assessment of wound closure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)