Status:
COMPLETED
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
Lead Sponsor:
MediWound Ltd
Conditions:
Venous Leg Ulcer
Diabetic Foot Ulcer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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...
Detailed Description
Up to fifteen (15) adult patients with \>50% non-viable tissue (necrotic/ slough/ fibrin) on the ulcer will be enrolled from up to 3 sites. Each patient will go through the following steps during the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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,
- Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.),
- Concurrent use of non-approved drugs or alcohol abuse,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Exposure to investigational intervention within 3 months prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled into the study
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04817228
Start Date
April 21 2021
End Date
May 20 2022
Last Update
July 26 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Barry University foot and ankle institute
Tamarac, Florida, United States, 33133
2
Clinical Research Medical Center, LLC
Las Vegas, Nevada, United States, 89119
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7212