Chronic UlcersNCT07406152
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
A study testing ZKARE® and Standard Wound Care in people with Chronic Ulcers, run by i+Med S.Coop. at 1 site in Spain.
Trial summary
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcers
- What is being tested?
- ZKARE® and Standard Wound Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years).
- Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic diabetic foot ulcers (grade I, II or III), Wagner Grade I-III or Texas 0, I, II, III / Stage B; class C6/C6r venous leg ulcers measured with CEAP scale ; neuro-ischaemic ulcers with adequate distal perfusion (ABI/ITB ≥ 0.7-0.89; mild PAD); mixed-etiology venous ulcers and any chronic lower-limb lesion with palpable distal pulses.
- Ulcer size between 1 cm² and 100 cm².
- Ability and willingness to comply with all study visits and procedures according to the clinical protocol.
- Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.
Who cannot join
- Ulcers of etiologies not listed in the inclusion criteria.
- Ischaemic, neoplastic or atypical ulcers.
- Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative/terminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III/IV or in dialysis.
- Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.
- Known allergy or sensitivity to any component of the investigational product.
- Any condition that, in the investigator's opinion, may compromise patient safety or adherence to the protocol.
- Pregnancy or planned breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Araba University Hospital
Vitoria-Gasteiz, Álava
Garbiñe Ruiz de Gordoa, +34 945 00 70 00, garbiñe.ruizdegordoacampo@osakidetza.eus
About this study
Official title: Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. The study includes 134 ulcers of different etiologies-pressure ulcers, neuropathic diabetic foot ulcers, and venous leg ulcers-meeting predefined selection criteria. Participants are randomized to receive either ZKARE® in addition to standard wound care or standard care alone.
The primary efficacy endpoint is the change in wound condition assessed through the RESVECH 2.0 scale, recorded at baseline and throughout treatment and follow-up visits. The primary safety endpoint is the incidence of serious adverse events (SAEs). Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, quality-of-life measures (DLQI), patient satisfaction, investigator global assessment, cost-effectiveness, and product usability. The study aims to generate evidence on the performance, safety, and clinical usefulness of ZKARE® for chronic wound management.
Read the detailed description
Chronic ulcers such as pressure ulcers, neuropathic diabetic foot ulcers and venous leg ulcers frequently fail to follow normal healing phases and require comprehensive management. Many existing dressings act through a single mechanism and are limited in effectiveness for complex or exudative wounds. ZKARE® is a sterile, biocompatible polymeric gel intended for topical use that provides a moist microenvironment, absorbs excess exudate and contributes to bacterial control. The product is applied using ZKAPI®, a sterile Luer-Lock applicator designed to improve precision and ease of administration.
This prospective, randomized, single-blind, controlled clinical investigation compares ZKARE® plus standard care with standard care alone in 134 chronic ulcers of different etiologies. Patients may contribute more than one ulcer if lesions are independent. After informed consent, ulcers are randomized, and treatment sessions follow routine clinical practice, with ZKARE® added only in the investigational arm. Blinding is maintained by preventing direct visualization of the wound and through iso-appearance of materials. Follow-up visits occur at approximately 2, 4, 8 and 12 weeks.
The primary efficacy endpoint is the change in RESVECH 2.0 score, recorded at baseline, each treatment session and all follow-up visits; a ≥2-point improvement at Week 4 is considered clinically relevant. The primary safety endpoint is the incidence of serious adverse events. Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, DLQI, patient satisfaction, investigator global assessment, usability and cost-effectiveness, as well as non-serious adverse events.
Group comparisons use appropriate statistical tests for categorical and continuous variables, repeated-measures analyses and ANCOVA where applicable, under an intention-to-treat approach. The sample size of 134 ulcers gives 80% power to detect expected differences in RESVECH 2.0 change. The study aims to evaluate the clinical performance and safety of ZKARE® and ZKAPI® in the treatment of chronic hard-to-heal ulcers
- Conditions
- Chronic Ulcers
- Being tested
- ZKARE®, Standard Wound Care
- Keywords
- Pressure ulcers, Hyaluronic acid, Wound healing, Topical gel, venous leg ulcers
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZKARE®Device
ZKARE® is applied topically after routine wound cleansing and debridement. Using the sterile ZKAPI® applicator, the gel is distributed to fully cover the wound bed, including irregular or cavitated areas. The treated wound is then covered with the appropriate secondary dressing following standard clinical practice. The application is repeated at each treatment session until complete closure or the end of the 12-week follow-up period. All sessions include RESVECH 2.0 scoring, standardized photographs, and safety assessments
Standard Wound CareProcedure or surgery
Standard care includes wound cleansing, debridement when required, and selection of secondary dressings according to wound characteristics such as exudate level, infection status, depth, and perilesional skin condition. No investigational gel is applied. At each treatment visit and follow-up time point, standardized wound photographs, RESVECH 2.0 scoring, closure metrics, and safety assessments are recorded according to the same schedule as the investigational arm.
| Study group | Role | What they receive |
|---|---|---|
| ZKARE® | Experimental | Participants assigned to this arm receive standard wound care plus topical application of the investigational gel ZKARE®, applied using the ZKAPI® applicator during each wound-care session. Receives: Device: ZKARE® |
| Standard Wound Care | Active comparator | Participants assigned to this arm receive standard wound management according to routine clinical practice, without the use of the investigational product. Receives: Procedure: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
RESVECH Scale 2.0
Change in the RESVECH 2.0 wound assessment scale, which evaluates wound size, depth, granulation tissue quality, exudate amount/type, clinical signs of infection/inflammation, and perilesional skin condition.
Measured at baseline and at each treatment and follow-up visit until complete closure or at week 12. A ≥2-point improvement at week 4 is considered clinically relevant.
Measured: 12 weeks or wound healing
Incidence of Serious Adverse Events (SAEs)
Incidence, frequency, and nature of serious adverse events during the study.
Measured: 12 weeks
Secondary outcomes (9)
Wound Closure Rate (mm²/day)
Rate of epithelialization based on the area healed divided by the time since treatment initiation.
Assessed at each treatment and follow-up visit.
Measured: 12 weeks
Percentage of Wound Closure (%)
Percentage reduction of the initial wound area at each assessment. A ≥30% reduction by week 4 is considered clinically relevant.
Kaplan-Meier curves may be used to evaluate closure thresholds (≥30%-90%).
Measured: 12 weeks
Total Wound Closure (%)
Percentage of wounds achieving complete epithelialization.
Measured: 12 weeks
Estimated Time to Full Closure (days)
For wounds not completely healed by week 12, linear regression based on closure rate is used to estimate time to complete healing.
Measured: 12 weeks
Cost-Effectiveness Analysis (Healthcare Resources Used)
Quantification of materials, products, consumables, and healthcare professional time in each treatment session.
Reported as €/patient.
Measured: 12 weeks
Dermatology Life Quality Index (DLQI) Score
Change in DLQI score (0-30), with higher scores indicating worse dermatology-related quality of life.
Measured: 12 weeks
Patient Satisfaction (Likert Scale)
Patient satisfaction rated at study end (Very dissatisfied, dissatisfied, neutral, satisfied and very satisfied).
Outcome to be reported as the percentage of "Satisfied" + "Very satisfied" answers.
Measured: 12 weeks
Investigator Global Assessment (IGA)
Clinical impression of overall wound evolution (Worsening / No improvement / Mild improvement / Significant improvement).
Outcome to be reported as the percentage of mild or significant improvement achievement.
Measured: 12 weeks
Incidence of Non-Serious Adverse Events (AEs)
Recording of the incidence and nature of all non-serious adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start14 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioaraba Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406152
- Sponsor's protocol ID
- ZKARE-PIC01-2025
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.
- ClinicalTrials.gov ID
- NCT07406152
- Acronym / sponsor ID
- ZKARE-PIC01-2025
- Conditions
- Chronic Ulcers
- Keywords
- Pressure ulcers, Hyaluronic acid, Wound healing, Topical gel, venous leg ulcers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Bioaraba Health Research Institute
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 Feb 2026 (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 prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. The study includes 134 ulcers of different etiologies-pressure ulcers, neuropathic diabetic foot ulcers, and venous leg ulcers-meeting predefined selection criteria. Participants are randomized to receive either ZKARE® in addition to standard wound care or standard care alone.
The primary efficacy endpoint is the change in wound condition assessed through the RESVECH 2.0 scale, recorded at baseline and throughout treatment and follow-up visits. The primary safety endpoint is the incidence of serious adverse events (SAEs). Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, quality-of-life measures (DLQI), patient satisfaction, investigator global assessment, cost-effectiveness, and product usability. The study aims to generate evidence on the performance, safety, and clinical usefulness of ZKARE® for chronic wound management.
Detailed description
Chronic ulcers such as pressure ulcers, neuropathic diabetic foot ulcers and venous leg ulcers frequently fail to follow normal healing phases and require comprehensive management. Many existing dressings act through a single mechanism and are limited in effectiveness for complex or exudative wounds. ZKARE® is a sterile, biocompatible polymeric gel intended for topical use that provides a moist microenvironment, absorbs excess exudate and contributes to bacterial control. The product is applied using ZKAPI®, a sterile Luer-Lock applicator designed to improve precision and ease of administration.
This prospective, randomized, single-blind, controlled clinical investigation compares ZKARE® plus standard care with standard care alone in 134 chronic ulcers of different etiologies. Patients may contribute more than one ulcer if lesions are independent. After informed consent, ulcers are randomized, and treatment sessions follow routine clinical practice, with ZKARE® added only in the investigational arm. Blinding is maintained by preventing direct visualization of the wound and through iso-appearance of materials. Follow-up visits occur at approximately 2, 4, 8 and 12 weeks.
The primary efficacy endpoint is the change in RESVECH 2.0 score, recorded at baseline, each treatment session and all follow-up visits; a ≥2-point improvement at Week 4 is considered clinically relevant. The primary safety endpoint is the incidence of serious adverse events. Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, DLQI, patient satisfaction, investigator global assessment, usability and cost-effectiveness, as well as non-serious adverse events.
Group comparisons use appropriate statistical tests for categorical and continuous variables, repeated-measures analyses and ANCOVA where applicable, under an intention-to-treat approach. The sample size of 134 ulcers gives 80% power to detect expected differences in RESVECH 2.0 change. The study aims to evaluate the clinical performance and safety of ZKARE® and ZKAPI® in the treatment of chronic hard-to-heal ulcers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZKARE® | Experimental | Device: ZKARE®Participants assigned to this arm receive standard wound care plus topical application of the investigational gel ZKARE®, applied using the ZKAPI® applicator during each wound-care session. |
| Standard Wound Care | Active comparator | Procedure: Standard Wound CareParticipants assigned to this arm receive standard wound management according to routine clinical practice, without the use of the investigational product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years).
- Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic diabetic foot ulcers (grade I, II or III), Wagner Grade I-III or Texas 0, I, II, III / Stage B; class C6/C6r venous leg ulcers measured with CEAP scale ; neuro-ischaemic ulcers with adequate distal perfusion (ABI/ITB ≥ 0.7-0.89; mild PAD); mixed-etiology venous ulcers and any chronic lower-limb lesion with palpable distal pulses.
- Ulcer size between 1 cm² and 100 cm².
- Ability and willingness to comply with all study visits and procedures according to the clinical protocol.
- Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.
Key exclusion criteria (7 listed)
- Ulcers of etiologies not listed in the inclusion criteria.
- Ischaemic, neoplastic or atypical ulcers.
- Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative/terminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III/IV or in dialysis.
- Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.
- Known allergy or sensitivity to any component of the investigational product.
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 |
|---|---|---|
| ZKARE®ZKARE® is applied topically after routine wound cleansing and debridement. Using the sterile ZKAPI® applicator, the gel is distributed to fully cover the wound bed, including irregular or cavitated areas. The treated wound is then covered with the appropriate secondary dressing following standard clinical practice. The application is repeated at each treatment session until complete closure or the end of the 12-week follow-up period. All sessions include RESVECH 2.0 scoring, standardized photographs, and safety assessments | Device | ZKARE® |
| Standard Wound CareStandard care includes wound cleansing, debridement when required, and selection of secondary dressings according to wound characteristics such as exudate level, infection status, depth, and perilesional skin condition. No investigational gel is applied. At each treatment visit and follow-up time point, standardized wound photographs, RESVECH 2.0 scoring, closure metrics, and safety assessments are recorded according to the same schedule as the investigational arm. | Procedure or surgery | Standard Wound Care |
Primary outcome
RESVECH Scale 2.0
Time frame: 12 weeks or wound healing
Change in the RESVECH 2.0 wound assessment scale, which evaluates wound size, depth, granulation tissue quality, exudate amount/type, clinical signs of infection/inflammation, and perilesional skin condition. Measured at baseline and at each treatment and follow-up visit until complete closure or at week 12. A ≥2-point improvement at week 4 is considered clinically relevant.
Incidence of Serious Adverse Events (SAEs)
Time frame: 12 weeks
Incidence, frequency, and nature of serious adverse events during the study.
9 secondary outcomes
Wound Closure Rate (mm²/day)
Time frame: 12 weeks
Percentage of Wound Closure (%)
Time frame: 12 weeks
Total Wound Closure (%)
Time frame: 12 weeks
Estimated Time to Full Closure (days)
Time frame: 12 weeks
Cost-Effectiveness Analysis (Healthcare Resources Used)
Time frame: 12 weeks
Dermatology Life Quality Index (DLQI) Score
Time frame: 12 weeks
Patient Satisfaction (Likert Scale)
Time frame: 12 weeks
Investigator Global Assessment (IGA)
Time frame: 12 weeks
Incidence of Non-Serious Adverse Events (AEs)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZKARE® and Standard Wound Care in people with Chronic Ulcers, run by i+Med S.Coop. at 1 site in Spain.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josune Torrecilla (+34945561134, jtorrecilla@imasmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RESVECH Scale 2.0 (time frame: 12 weeks or wound healing). The study lists 2 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 4 Nov 2026.