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Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

ConditionVenus Leg Ulcers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediWound Ltd

About this trial

The main objective of this study is:

To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women, older than 18 years of age,

Patients 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 1 year,

The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • EscharEx (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 wound area.

  • Placebo (Gel vehicle)

    Drug

    A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: EscharEx (EX-03)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: CollagenaseOther 2 interventions

Trial outcomes

Primary outcomes

1

Incidence (number of patients) of target wound related AEs throughout the trial

The endpoint will assess number of patients, in each arm, with reported local (target wound related) AEs

Time frame
Throughout the study (week 2- week 15)
2

Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,

Number of patients with Clinically significant changes in vital signs

Time frame
Weeks 2-3 (14 days)
3

Number of patients with Clinically significant changes in clinical laboratory parameters

Number of patients with Clinically significant changes in clinical laboratory parameters

Time frame
Weeks 2-3 (14 days)
4

Time to complete wound closure

The outcome will assess time to reaching complete wound closure

Time frame
Weeks 2-15

Secondary outcomes

1

Incidence of complete debridement

the outcome will assess number of patients with complete debridement assessed clinically

Time frame
Up to 8 applications (14 days)
2

Incidence of complete healthy viable granulation tissue

the outcome will assess number of patients with complete healthy viable granulation tissue on the treated wound, assessed clinically

Time frame
Up to 8 applications (14 days)

Other outcomes

Sponsors and contacts

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

MediWound Ltd

Lead sponsor

Source ClinicalTrials.gov

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