Diabetic Foot, Foot Ulcer, Diabetic, Venous Ulcer, Wound Healing
Conditions
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).
Interventions
DEVICEEDX110 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
Sponsors
ConvaTec Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | up to 12 week | Number and type of wound and device-related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Countries
Chile
Outcome results
None listed