A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

NCT04817228 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MW 2020-08-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

Conditions

Venous Leg Ulcer; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (4)

• Incidence of complete debridement

  Incidence of complete debridement assessed clinically

  up to 14 days

• Time to complete debridement

  Time to complete debridement assessed clinically

  up to 14 days

• Change from baseline in wound fluid biomarkers

  Wound healing biomarkers (MMP2, MMP9, HNE, PDGF, IL8, TNFR1) distribution in wound fluid will be compared before and after completion of treatment

  up to 14 days

• Change from baseline in wound biofilm presence before and after treatment

  Biofilm presence in wound will be compared before and after completion of treatment, using punch biopsy from wound

  up to 14 days

Study Arms (1)

EX-02 Gel

EXPERIMENTAL

The powder of EX-02 (8.1 g in each unit) should be reconstituted with 20 g sterile water for injection (WFI) to obtain 5% EX-02. EX-02 5% gel will be topically applied on a wound surface of up to 80 cm2 for 24±3 hours, up to 8 consecutive applications

Drug: EscharEx (EX-02 formulation)

Interventions

EscharEx (EX-02 formulation) DRUG

EscharEx (EX-02 formulation) gel is topically applied on a wound surface of up to 80 cm2 , up to 8 consecutive applications or until a complete debridement is achieved, whichever occurs first.

EX-02 Gel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, men or women, between 18 and 90 years of age,
• Patients with a VLU (determined by medical history, physical examination or an ultrasound scan demonstrating venous insufficiency) or DFU (determined by medical history, and physical examination),
• Wound is present for at least 4 weeks but no longer than 2 years,
• The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation),
• Target wound surface area is in the range of 2-80 cm2,
• Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure.

You may not qualify if:

• Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2cm2,
• Signs of clinically significant infection including purulent discharge, deep-tissue abscess, erysipelas, cellulitis at the surrounding skin, etc.,
• Severely damaged skin at the per wound (e.g. abrasion, exfoliation) extending \>2 cm around the wound's edge,
• Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
• Clinical suspicion of skin cancer (e.g. BCC, SCC, melanoma, sarcoma), which was not ruled out by biopsy (in this case a biopsy will be performed before screening),
• Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma Gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
• Wound has sinus tracts or tunnels extending under the skin \>2 cm surrounding subcutaneous structures, or penetrating into joint capsule,
• A significant decrease in the arterial blood flow of the extremity,
• Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by silver, silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a result of SSD treatment),
• History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
• Patients with poor nutritional status: albumin \< 3.0 g/dl, poorly controlled Diabetes Mellitus (for diabetic patients; HbA1c \> 12%), anemia (hemoglobin\<8 g/dL), a leukocyte counts \< 4,000/ μl or \>15000/μl, Neutrophils \< 1500/ul, platelets \<100,000/μl, abnormal liver function (AST, ALT\>2 x upper limit of normal range), total bilirubin \> 1.5 mg/dl, renal failure (Cr \> 2.5 mg/dl), BMI\>45,
• Patients undergoing renal or peritoneal dialysis,
• Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, positive for COVID-19 or neoplastic disease, or any immediate life threatening condition,
• Recent history (less than 6 months) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patient's welfare,
• Patient is currently receiving, or has received at any time within the past 30 days any medications or treatments known to affect the wound healing processes; these include, chronic systemic steroid intake ( \>10 mg/ day) with topical skin changes (i.e. thin, fragile skin with multiple heamatomas or previous laceration history) immuno-suppressive drugs, radiation therapy, immunomodulating medications and chemotherapy,

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (3)

Barry University foot and ankle institute

Tamarac, Florida, 33133, United States

Location

Clinical Research Medical Center, LLC

Las Vegas, Nevada, 89119, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599-7212, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Lior Rosenberg, Prof.

  MediWound Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 26, 2021
• Study Start: April 21, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 20, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

US (3)