EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds

NCT06640985 | Active Not Recruiting

• 1 other identifier: WC-24-446
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Post-market study to determine the efficacy of EDX110 dressing system in hard-to-heal wounds.

Conditions

Wound Healing; Diabetic Foot; Foot Ulcer, Diabetic; Venous Ulcer

Outcome Measures

Primary Outcomes (1)

• Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs

  Percentage area reduction (PAR) of target wound at 12 weeks for each wound determined by wound measurements

  12 week

Secondary Outcomes (3)

• Efficacy of EDX110 in complete wound management and healing of hard-to-heal wounds

  4 week

• Effect of EDX110

  Treatment, week 4 and 12

• Tolerability of EDX110

  up to 12 week

Other Outcomes (1)

• Complications

  up to 12 week

Study Arms (2)

Diabetic Foot Ulcer (DFU)

EXPERIMENTAL

DFU treatment with EDX110 wound dressing

Device: EDX110 wound dressing system

Venous Leg Ulcer (VLU)

ACTIVE COMPARATOR

VLU treatment with EDX110 wound dressing

Device: EDX110 wound dressing system

Interventions

EDX110 wound dressing system DEVICE

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

Diabetic Foot Ulcer (DFU); Venous Leg Ulcer (VLU)

Eligibility Criteria

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

You may qualify if:

• Subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
• An index ulcer meeting the following characteristics:
• Diabetic foot ulcer (DFU): Wagner Grade 1: partial- or full-thickness (superficial)
• DFU: Located on the anatomical foot; defined as distal to the medial malleolus
• Venous leg ulcer (VLU): Partial or full thickness
• VLU: Located below the knee and above the ankle
• Presents with or without clinical signs of superficial infection
• Present for ≥4 weeks and \<52 weeks
• Wounds will be dry to moderately exudating
• Post-debridement wound area is ≥0.5 cm2 and ≤25 cm2
• If two or more ulcers are present, the index ulcer must additionally be:
• The ulcer with the largest wound area
• ≥3cm distance from any other ulcer on the affected limb
• DFU: type 1 or type 2 diabetes (confirmed by the subject's medical history)
• DFU: HgbA1c \<9% at screening

You may not qualify if:

• Subjects with wounds that have any of the following characteristics:
• Wounds that penetrate down to tendon, ligament, joint capsule or bone, underlying muscle tissue, or organs
• Tunnelling wounds
• Known or suspected local skin malignancy at the site of the ulcer
• DFU: Major structural abnormalities of the foot
• DFU: Active Charcot deformity
• VLU: inability to tolerate elastocompression (40 mm/hg)
• Wound duration \>1 year
• Subjects receiving any of the following prior therapies:
• In the last 10 days:
• Chemical debridement
• Dakin's solution
• Medical honey therapy
• In the last 30 days (or anticipated to require such medications during the study period):
• Cytotoxic chemotherapy

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Convatec Medical Care

Santiago, Chile

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

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; Varicose Veins

Study Officials

• Jeison David Peñuela, MD

  Convatec Medical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: December 4, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CL (1)