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An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers

ConditionVenous Leg Ulcer (VLU)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediWound Ltd

About this trial

This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women, older than 18 years of age,

Participants with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),

Wound is present for at least 4 weeks but no longer than 2 years,

The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, is at least 50% of the wound area (assessed by clinical evaluation),

Disqualifiers

Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period,

Participants with more than one leg ulcer , on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2 cm and 5 cm away from the edge of the target wound,

Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,

Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,

Trial design

Design model

Single group

Treatments tested in this trial

  • EX-03

    Drug

    a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the w

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EscharEx (EX-03)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PK Evaluation

Cmax (maximal observed serum concentration),

Time frame
Up to 2 weeks
2

Safety and Tolerability Endpoints

Incidence and severity of systemic and local adverse events (AEs),

Time frame
up to 5 weeks
3

PK Evaluation

AUC (area under the concentration -time curve)

Time frame
Up to 2 weeks

Secondary outcomes

1

Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications)

counting events of complete debridement

Time frame
up to 2 weeks
2

Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically

counting events of complete granulation

Time frame
up to 2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MediWound Ltd

Lead sponsor

TFS HealthScience

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: