Venous Leg UlcerPhase 2NCT04817228
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
A Phase 2 study testing EscharEx (EX-02 formulation) in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by MediWound Ltd at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- EscharEx (EX-02 formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2021to 20 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27599-7212
Clinical Research Medical Center, LLC
Las Vegas, Nevada, 89119
Barry University foot and ankle institute
Tamarac, Florida, 33133
About this study
Official title: A Prospective Study Performed to Evaluate the Clinical Performance (Debridement), Safety and Pharmacology Effect of EscharEx (EX-02 Formulation) in Patients With Lower Leg Ulcers (VLU and DFU)
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).
Read the 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 trial:
- Screening and Inform Consent signing - screening visit duration will be up to 1 week and will include: recording demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and pain assessment questionnaires. Wound fluid sampling and 3 mm punch biopsy (from the wound edge area) will be taken during screening.
- Daily visits period (up to 8 daily site visits within up to 14 days), including an additional visit, 48 hrs after last daily visit for wound fluid sampling. During the Daily visits period, the patient will arrive daily to site visits. During each visit, adverse events (AEs), concomitant medications, vital signs, and pain will be assessed and recorded, the wound will be washed, photographed and assessed for wound size and for % of nonviable tissue by clinical assessment. During the daily visits period, the peri-wound will be well protected with topical barrier (e.g zinc oxide paste). For VLU, compression therapy must be used throughout daily visits period. The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. Patients will be treated with EX-02 for up to 8 applications (up to 8 visits) or until complete debridement is achieved, whichever occurs first. Duration of each application will be 24±3 hours. On weekends occurring during the daily visits period the wound will be dressed with a non-active dressing (e.g. foam). Hydrogels as well as methods of active debridement (either surgical, mechanical, biological, enzymatic or other dressings), grafting and V.A.C are not allowed during this period and while daily visits are ongoing. Fluid samples will be taken from the EX-02 treated wound before the first treatment and once the wound has reached complete debridement or daily visits completed, whichever occurred first. Punch biopsies from the wound edge will be taken before and at the end of the debridement to assess for biofilm. Clinical lab tests and physical examination as well as pain assessments and vital signs will be performed at the end of daily visits period (once the wound has reached complete debridement or daily visits completed, whichever occurred first). For patients who achieved complete debridement, wound closure could be considered using grafting/autograft procedure. After completion of the daily visits period (either if complete debridement was achieved, or after 8 daily applications were performed) patients will start the weekly follow- up period.
- Weekly follow- up period (2 visits in 2 weeks) - the 2 weekly follow up period should be performed at the clinical site. During each weekly visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size and for % of nonviable tissue.
For wounds which did not reach complete debridement during the daily visits period, the investigator should continue to persue complete debridement using surgical or non- surgical debridement tools (SOC), per the investigators discretion.
Compression therapy must be used throughout this period for VLU patients and as determined by investigator to be appropriate for DFU.
The overall duration of the study for each patient will be approximately 4-5 weeks.
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Being tested
- EscharEx (EX-02 formulation)
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: EscharEx (EX-02 formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete debridement
Incidence of complete debridement assessed clinically
Measured: up to 14 days
Time to complete debridement
Time to complete debridement assessed clinically
Measured: 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
Measured: 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
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start21 Apr 2021
- Primary completion6 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lior Rosenberg, Prof., Study chair, MediWound Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817228
- Sponsor's protocol ID
- MW 2020-08-01
- Status last verified
- Jul 2022
- First submitted
- 16 Mar 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Performed to Evaluate the Clinical Performance (Debridement), Safety and Pharmacology Effect of EscharEx (EX-02 Formulation) in Patients With Lower Leg Ulcers (VLU and DFU)
- ClinicalTrials.gov ID
- NCT04817228
- Acronym / sponsor ID
- MW 2020-08-01
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 trial:
- Screening and Inform Consent signing - screening visit duration will be up to 1 week and will include: recording demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and pain assessment questionnaires. Wound fluid sampling and 3 mm punch biopsy (from the wound edge area) will be taken during screening.
- Daily visits period (up to 8 daily site visits within up to 14 days), including an additional visit, 48 hrs after last daily visit for wound fluid sampling. During the Daily visits period, the patient will arrive daily to site visits. During each visit, adverse events (AEs), concomitant medications, vital signs, and pain will be assessed and recorded, the wound will be washed, photographed and assessed for wound size and for % of nonviable tissue by clinical assessment. During the daily visits period, the peri-wound will be well protected with topical barrier (e.g zinc oxide paste). For VLU, compression therapy must be used throughout daily visits period. The investigator will clinically assess complete debridement, upon achieving a viable wound bed after removal of all non-viable tissue, suitable for initiation of the wound healing stage. Patients will be treated with EX-02 for up to 8 applications (up to 8 visits) or until complete debridement is achieved, whichever occurs first. Duration of each application will be 24±3 hours. On weekends occurring during the daily visits period the wound will be dressed with a non-active dressing (e.g. foam). Hydrogels as well as methods of active debridement (either surgical, mechanical, biological, enzymatic or other dressings), grafting and V.A.C are not allowed during this period and while daily visits are ongoing. Fluid samples will be taken from the EX-02 treated wound before the first treatment and once the wound has reached complete debridement or daily visits completed, whichever occurred first. Punch biopsies from the wound edge will be taken before and at the end of the debridement to assess for biofilm. Clinical lab tests and physical examination as well as pain assessments and vital signs will be performed at the end of daily visits period (once the wound has reached complete debridement or daily visits completed, whichever occurred first). For patients who achieved complete debridement, wound closure could be considered using grafting/autograft procedure. After completion of the daily visits period (either if complete debridement was achieved, or after 8 daily applications were performed) patients will start the weekly follow- up period.
- Weekly follow- up period (2 visits in 2 weeks) - the 2 weekly follow up period should be performed at the clinical site. During each weekly visit, safety parameters will be recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed, photographed and assessed for wound size and for % of nonviable tissue.
For wounds which did not reach complete debridement during the daily visits period, the investigator should continue to persue complete debridement using surgical or non- surgical debridement tools (SOC), per the investigators discretion.
Compression therapy must be used throughout this period for VLU patients and as determined by investigator to be appropriate for DFU.
The overall duration of the study for each patient will be approximately 4-5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EX-02 Gel | Experimental | Drug: EscharEx (EX-02 formulation)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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (19 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscharEx (EX-02 formulation)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. | Drug | EX-02 Gel |
Primary outcome
Incidence of complete debridement
Time frame: up to 14 days
Incidence of complete debridement assessed clinically
Time to complete debridement
Time frame: up to 14 days
Time to complete debridement assessed clinically
Change from baseline in wound fluid biomarkers
Time frame: up to 14 days
Wound healing biomarkers (MMP2, MMP9, HNE, PDGF, IL8, TNFR1) distribution in wound fluid will be compared before and after completion of treatment
Change from baseline in wound biofilm presence before and after treatment
Time frame: up to 14 days
Biofilm presence in wound will be compared before and after completion of treatment, using punch biopsy from wound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lior Rosenberg, Prof. study chair
MediWound Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EscharEx (EX-02 formulation) in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by MediWound Ltd at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete debridement (time frame: up to 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.