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

Not Applicable

Not yet recruiting

• Conditions: Wound Healing; Diabetic Foot; Foot Ulcer, Diabetic; Venous Ulcer

• Registration Number: NCT06640985
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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

Detailed Description

Prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of EDX110 dressing system in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Study Start: 2024-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

• GFR>30 mL/min/1,73m2

• Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following results within the past 30:

  • Dorsum transcutaneous oxygen test (TcPO2): >30mmHg;
  • Subject's Ankle-Brachial Index (ABI) by Doppler: ≥0.7 and ≤1.2;
  • Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For Ankle-Brachial Pressure Index (ABPI): >1.2, for Toe Brachial Index (TBI): >0.5

• A total lymphocyte count of more than 1500 cells/mm3

• Albumin level of more than 3.5 g/dL

• Subject can ambulate at home or in the clinic with or without mobility aids

• BMI ≤45

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Exclusion Criteria

• 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
    • Application of topical steroids to the ulcer surface
    • Use of ≥14 days of immune suppressants (including systemic corticosteroids) OR
    • Subject is anticipated to require such medications during the study period

  • In the last 30 days:

    o Study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials

  • In the last 6 months:

    • Any amputation to the affected leg
    • Revascularization (surgical or stenting) to the affected leg

• Known hypersensitivity to constituents of the product

• Osteomyelitis/bone infection of the affected foot/leg, as verified by x-ray within 30 days prior to screening

• Active cellulitis at the wound site

• History of radiation at the ulcer site, regardless of duration

• Chronic kidney disease stage 4 or 5

• Immune system disorders, including SLE, AIDS or HIV

• Presence of any other pathology that would limit blood supply and compromise healing

• Revascularization procedure to increase blood flow in the target limb

• Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study

• Women of childbearing age (women aged <55 years who have not undergone menopause) who are:

  • Pregnant at time of enrolment
  • Planning to become pregnant during the time of the study
  • Have been pregnant within the last 6 months
  • Breast-feeding
  • Unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the time of the study
  • Concurrent enrolment in any other study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of EDX110 in reducing the wound size of commonly occurring hard-to-heal wounds: DFUs and VLUs	12 week	Percentage area reduction (PAR) of target wound at 12 weeks for each wound determined by wound measurements

Secondary Outcome Measures

Name	Time	Method
Efficacy of EDX110 in complete wound management and healing of hard-to-heal wounds	4 week	PAR of target wound as defined as 100% reepithelialization
Effect of EDX110	Treatment, week 4 and 12	Treatment effect by using the 17-item Wound Quality of Life (W-QoL) questionnaire, assessing how wound care has affected the quality of life in the last seven days, ranging from "Not at all" to "Very much"
Tolerability of EDX110	up to 12 week	Tolerability assessed by Visual Analog Scale (VAS), assessing overall impression and satisfaction, ranging from "Very Poor" to "Excellent"

Trial Locations

Locations (1)

Convatec Chile Clinic