Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MediWound Ltd
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients, men or women, between 18 and 90 years of age,
2. Patients with a VLU (determined by medical history, physical examination, and an ultrasound scan demonstrating venous insufficiency),
3. Wound is present for at least 4 weeks but no longer than 2 years.
4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation),
5. Target wound surface area is in the range of 2-100 cm2 (assessed by eKare inSightTM),
6. 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 be if
1. Wound size decreased by \> 20% after 1 week of standard-of-care-only period (screening period),
2. Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2cm2,
3. Signs of clinically significant infection including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
4. Severely damaged skin (e.g. abrasion, exfoliation) extending \>2 cm around the wound's edge,
5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
6. Clinical suspicion of skin cancer (e.g. BCC, SCC, melanoma, sarcoma), which was not ruled out by biopsy,
7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma Gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
9. Wound has sinus tracts or tunnels extending under healthy tissue (following debridement "un-roofing"- if relevant), or penetrating into joint capsule,
10. Vascular operations in proximity to the wound in the last month,
11. Patients with primary lymphatic edema,
12. A significant decrease in the arterial blood flow of the extremity
13. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a result of SSD treatment),
14. 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,
15. Patients with poor nutritional status: albumin \< 2.5g/dl, poorly controlled Diabetes Mellitus (for diabetic patients; HbA1c \> 12%), anemia (hemoglobin\<8 g/dL), a leukocyte counts \< 3,800// μl or \>15000/μl, platelets \<100,000/μl, abnormal liver function (AST, ALT\>2 x upper limit of normal range), renal failure (Cr \> 2.5 mg/dl), BMI\>48,
16. Patients undergoing renal or peritoneal dialysis,
17. Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or neoplastic disease, or any immediate life threatening condition,
18. Recent history (less than 6 months) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patient's welfare,
19. Patient is currently receiving, or has received at any time within three months prior to enrollment, any medications or treatments known to affect the wound healing processes; these include, chronic systemic steroid intake 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,
20. Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.),
21. Concurrent use of non-approved drugs or alcohol abuse,
22. Pregnant women (positive pregnancy test) or nursing mothers,
23. Exposure to investigational intervention within three months prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.
