Hard to Heal WoundsPhase 2NCT02020746
Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
A Phase 2 study testing EscharEx in people with Hard to Heal Wounds and Venous Leg Ulcers, run by MediWound Ltd at 8 sites in Israel.
Trial summary
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hard to Heal Wounds, Venous Leg Ulcers, Diabetic Lower Extremity Ulcers
- What is being tested?
- EscharEx
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 8 sitesIsrael
- Study dates
- 24 Jul 2014to 4 Jun 2018
- 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, are between 18 and 90 years of age.
- Patient with venous leg ulcer or diabetic (lower extremity) ulcer or traumatic/post operative wound (determined by medical history and physical examination)
- Wound is not healing for at least 4 weeks
- The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation)
- Wound surface area is in the range of 5- 200 cm2 in the first stage and 3 - 150cm2 in the second stage.
- Patient understands the nature of the procedure, able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure
- The Wound is classified as a wound involving full skin thickness but not penetrating to cavities or open joint spaces
Who cannot join
- Evidence of active osteomyelitis of target organ,
- Patients with more than one hard to heal wounds wounds which require debridement and with an area greater than or equal to 2cm2,
- Presence of purulent discharge, deep-tissue abscess, cellulitis or tissue damage extending >2 cm around the wound's edge, gangrene or signs of systemic infection,
- Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening period),
- Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by Silver sulfadiazine (SSD) pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
- Ankle-Brachial Index (ABI) ≤ 0.7 or a significant decrease in the blood flow of the extremity as demonstrated by US doppler.
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- Wound has sinus tracts or tunnels extending under healthy tissue,
- Patients undergoing renal or peritoneal dialysis,
- Recent history (less than 4 weeks) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patient's welfare,
- Any condition that would preclude safe participation in the study: evidence of significant hematological (severe pre-existing coagulation disorder), cardiovascular, liver or neoplastic disease, or any other immediate life threatening condition,
- Patient is currently receiving, or has received at any time within one month prior to enrollment, any medications or treatments known to affect the wound healing processes; these include: chronic systemic steroid intake with topical skin changes (thin, fragile with multiple hematomas and previous laceration history, immuno-suppressive drugs, radiation therapy and chemotherapy.
- History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Participation in another investigational drug trial within 30 days prior to enrollment or anticipated participation while enrolled in the study,
- Concurrent use of non-approved drugs or alcohol abuse.
- Patients with poor nutritional status (albumin < 2.5g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 4,000// μl or >15000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 3 mg/dl);
- Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc),
- Patients with general skin disorders (Psoriasis, Panniculitis, ect) that might deteriorate as a result of local trauma.
- Patients with skin disorders unrelated to the wound that are presented adjacent to the wound
- Clinical suspicion of skin cancer associated with the wound (e.g, BCC, SCC), which was not ruled out by biopsy Patients with diagnosed Sepsis during screening phase,
- Patients suffering from Idiopathic Pruritus.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Israel8 sites
Emek
Afula
Rambam MC - Plastic surgery ward
Haifa
Meir MC
Kfar Saba
Galilee
Nahariya
HaSharon hospital, Rabin MC
Petah Tikva
Sheba MC
Ramat Gan
Kaplan
Rehovot
Assaf HaRofeh
Zrifin
About this study
Official title: A Multicenter, International, Prospective, Randomized, Vehicle Controlled, Assessor Blinded Study Performed in Subjects With Hard to Heal Wounds, to Evaluate the Efficacy and Safety of Enzymatic Debridement With EscharEx
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds.
This study will be a multi-center, assessor blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds.
Read more
72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled into the study.
Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. Following each application the wound will be washed, photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are performed, in the second stage). Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure.
- Conditions
- Hard to Heal Wounds, Venous Leg Ulcers, Diabetic Lower Extremity Ulcers, Traumatic/ Post Operative Wounds
- Being tested
- EscharEx, Gel Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscharExDrug
Gel VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| EscharEx | Active comparator | Enzymatic debridement Receives: Drug: EscharEx |
| Gel Vehicle | Placebo comparator | Control arm Receives: Drug: Gel Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete debridement (non-viable tissue removal) at the end of the debridement period assessed by the blinded assessor by clinical evaluation.
Measured: up to 10 treatment days
Secondary outcomes (1)
Rate of complete wound closure
Measured: 12 weeks post debridement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study start24 Jul 2014
- Primary completion5 Dec 2017
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hard to Heal WoundsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020746
- Sponsor's protocol ID
- MW 2013-07-10
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2013
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, International, Prospective, Randomized, Vehicle Controlled, Assessor Blinded Study Performed in Subjects With Hard to Heal Wounds, to Evaluate the Efficacy and Safety of Enzymatic Debridement With EscharEx
- ClinicalTrials.gov ID
- NCT02020746
- Acronym / sponsor ID
- MW 2013-07-10
- Conditions
- Hard to Heal Wounds, Venous Leg Ulcers, Diabetic Lower Extremity Ulcers, Traumatic/ Post Operative Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 25 Dec 2013 (estimated)
- 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.
The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds.
This study will be a multi-center, assessor blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds.
72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled into the study.
Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. Following each application the wound will be washed, photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are performed, in the second stage). Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EscharEx | Active comparator | Drug: EscharExEnzymatic debridement |
| Gel Vehicle | Placebo comparator | Drug: Gel VehicleControl arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients, men or women, are between 18 and 90 years of age.
- Patient with venous leg ulcer or diabetic (lower extremity) ulcer or traumatic/post operative wound (determined by medical history and physical examination)
- Wound is not healing for at least 4 weeks
- The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation)
- Wound surface area is in the range of 5- 200 cm2 in the first stage and 3 - 150cm2 in the second stage.
Key exclusion criteria (21 listed)
- Evidence of active osteomyelitis of target organ,
- Patients with more than one hard to heal wounds wounds which require debridement and with an area greater than or equal to 2cm2,
- Presence of purulent discharge, deep-tissue abscess, cellulitis or tissue damage extending >2 cm around the wound's edge, gangrene or signs of systemic infection,
- Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening period),
- Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by Silver sulfadiazine (SSD) pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
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 | Drug | EscharEx |
| Gel Vehicle | Drug | Gel Vehicle |
Primary outcome
Incidence of complete debridement (non-viable tissue removal) at the end of the debridement period assessed by the blinded assessor by clinical evaluation.
Time frame: up to 10 treatment days
1 secondary outcome
Rate of complete wound closure
Time frame: 12 weeks post debridement
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 31 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 in people with Hard to Heal Wounds and Venous Leg Ulcers, run by MediWound Ltd at 8 sites in Israel.
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 7 inclusion and 21 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel. 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. Some participants in this study may receive a placebo. 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 (non-viable tissue removal) at the end of the debridement period assessed by the blinded assessor by clinical evaluation. (time frame: up to 10 treatment days). 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 31 Aug 2018.