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Diabetic Foot Ulcer (DFU)Phase 1/2RESCUE-PATCHNCT07048054

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers

A Phase 1/2 study testing TrophiPatch: allogeneic adipose-derived stromal cell patch in people with Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU), run by Nicolò Brembilla at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TrophiPatch: allogeneic adipose-derived stromal cell patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSwitzerland
Study dates
Jul 2025to Dec 2026
Phase
Phase 1/2
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

  • Age 18 years or older.
  • Patients with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.
  • Participants will have the capacity to understand study procedures, and will be able to providewritten informed consent.
  • (for VLU only)
  • Diagnosed with at least one venous leg ulcer.
  • Ulcers duration for 6 weeks to 3 years at the time of screening.
Show all 19Show fewer
  • Hard-to-healed ulcers with cross-sectional area that have decreased by less than 40% during a four-week run-in period.
  • Reference ulcer surface from 5 to 25 cm2.
  • At the time of inclusion, the ulcer will be clinically non-infected (TILI score ≥ 5).
  • Absence of significant arterial insufficiency assessed at clinical examination (intermittent claudication or resting pain, necrotic or distal wound on the foot) and systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.
  • (for DFU only)
  • Patient with type 1 or type 2 diabetes.
  • Diagnosed with at least one diabetic foot ulcer on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.
  • Ulcers duration for 4 weeks to 3 years at the time of screening.
  • Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four-week run-in period.
  • Reference ulcer surface from 1 to 25 cm2.
  • At the inclusion, the ulcer will be clinically non-infected (according to IDSA criteria).
  • HbA1C < 12% at screening.
  • Absence of significant arterial insufficiency assessed by systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.

Who cannot join

  • Subject has a history of:
  • endstage renal disease
  • uncontrolled cardiac failure
  • severe malnutrition
  • severe liver disease
  • aplastic anemia
Show all 28Show fewer
  • malignant disease (active or recent (<5 years))diabetes avec HbA1C > 12%
  • rheumatoid arthritis
  • sickle cell disease
  • other connective tissue disorder
  • irradiation to the affected extremity
  • Serum creatinine concentration greater than 180 umol/L and/or receipt of renal dialysis or an estimated glomerular filtration rate (based on cystatin C or serum creatinine) of less than 20 mL/min per 1·73 m²
  • Drug or alcohol abuse.
  • Limited physical capacity or total immobility.
  • Known pregnancy or nursing at the time of screening visit
  • Subject is currently receiving (i.e within 30 days prior to inclusion) or scheduled to receive a medication or treatment that, in the opinion of the investigator, will interfere with or affect the rate of wound healing.
  • Index ulcers probing to tendon, muscle, capsule and bone.
  • Local or systemic signs of ongoing infection.
  • Hypersensitivity to silicone or porcine gelatin.
  • Previous treatment with growth factors, stem cells, or an equivalent preparation within the 8 weeks before the baseline visit.
  • Involvement in another interventional clinical trial within the 4 weeks before the baseline visit.
  • Known or suspected absence of capacity to understand the study procedures or provide written informed consent (decided by the investigator).
  • Cross-sectional area of the index ulcer had increased by at least 20%.
  • (for VLU only)
  • History of poor compliance with compression therapy.
  • Presence of peripheral neuropathy of the lower limbs.
  • (for DFU only)
  • History of poor compliance with offloading therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolo C Brembilla, Dr contact

0041(0)22 3795751

nicolo.brembilla@hug.ch

Switzerland1 site, 1 recruiting

  • University Hospitals of Geneva

    Geneva

    Recruiting

Other trials in Switzerland

About this study

Official title: Allogenic Adipose-derived Stromal Cell Patch (i.e TrophiPatch, Provided by HekeTiss®) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy, a One-arm Monocentric Phase I-ll Trial

This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies.

All 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.

Being tested
TrophiPatch: allogeneic adipose-derived stromal cell patch
Medical subject headings
Diabetic Foot, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrophiPatch: allogeneic adipose-derived stromal cell patchDrug

    Topical application of an allogeneic adipose-derived stromal cell patch

Study groups in NCT07048054
Study groupRoleWhat they receive
TrophiPatch treatmentExperimentalone time application of TrophiPatch
Receives: Drug: TrophiPatch: allogeneic adipose-derived stromal cell patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite safety outcome at week 12 from baseline

    Composite outcome including any of the following events: deterioration of the ulcer, as measured by an increase of the ulcer size of > than 20% at week 12 as compared to d0; and/or presence of spreading infection or systemic infections (criteria according to IWII); and/or presence of treatment-related irritative or allergic contact dermatitis (as per clinical diagnosis)

    Measured: Week 12

Secondary outcomes (12)

  1. Number of patients with localised infection (TILI score ≥ 5) not suspicious for irritative or allergic contact dermatitis

    Measured: Week 12

  2. Extent of pruritus, as determined by Numerical Rating Score (NRS).

    Eleven numbers from 0 to 10 are displayed and patients are asked to pick the number corresponding to the intensity of their pruritus

    Measured: Week 12

  3. Number of patients with hyper-cicatrisation

    Clinical evaluation

    Measured: Week 12

  4. Number of patients with pathologic scar

    clinical evaluation of cheloid or hypertrophic scar

    Measured: Week 12

  5. Number of patients developing donor-HLA antibodies

    Measured: Week 12

  6. Weekly change in ulcer area till week 12

    Standardised measurement of the wound area will be performed once weekly in the occasion of the first visit of the week using the SilhouetteTM camera. Change of wound area will be calculated by subtracting the surface area at week X to that measured at d0. This will be expressed as % of change with respect to d0.

    Measured: from enrolment to week 12

  7. Number of completely healed and epithelised ulcers at week 12.

    Visual inspection of the ulcer at week 12 and evaluation of the corresponding digital image as acquired via the Silhouette camera. The ulcer will be considered completely healed if presenting an epithelial layer and persisting for 2 weeks.

    Measured: Week 12

  8. Weekly evolution of the wound bed score till week 12

    The wound bed score consists of 8 key components: (a) healing edges (wound edge effect); (b) black eschar; (c) greatest wound depth/granulation tissue; (d) amount of exudate, edema, peri-wound dermatitis, peri-wound callus and fibrosis; and (e) a pink wound bed. Each of these components is scored individually.. The maximum score (best score) is 16. The minimum possible score (worst score) is 0.

    Measured: From enrolment to week 12

  9. Evolution of the quality of blood perfusion of the wound

    The quality of vascularisation and the measurement of local oxygen (transcutaneous oximetry - tcpO2) will be determined by laser doppler imaging

    Measured: Week 2 and week 12

  10. Reduction in pain during the study period

    Pain will be measured using the Visual Analog Scale (VAS), a 10-centimeter horizontal line anchored by two extremes: "no pain" (score = 0) and "worst imaginable pain" (score = 10). Participants will indicate their pain level by marking a point on the line. Higher scores indicate worse pain.

    Measured: From enrolment to week 12

  11. Change in quality of life

    Change in quality of life will be assessed using the Wound-QoL questionnaire, a validated 17-item instrument specifically designed for patients with chronic wounds. Scores range from 0 to 4, with higher scores indicating worse quality of life.

    Measured: Day 0 and week 12

  12. Assessment of patient-relevant benefits during wound therapy

    Assessment of patient-relevant benefits during wound therapy will be conducted using the Patient Benefit Index (PBI), specifically the validated short version (PBI-S 2.0) and the PBI for chronic wounds (PBI-W). The PBI includes two parts: the Patient Needs Questionnaire (PNQ), where patients rate the importance of treatment goals, and the Patient Benefit Questionnaire (PBQ), where they rate the extent to which these goals were achieved. A weighted algorithm combines these ratings into a global PBI score ranging from 0 (no benefit) to 4 (maximum benefit). A score ≥ 1 is considered a clinically relevant benefit, while a score ≥ 3 reflects a high patient-reported benefit. Higher scores indicate greater perceived benefit from the therapy.

    Measured: Day 0 and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
One-arm monocentric phase I/lla trial of allogenic adipose-derived stromal cells for the treatment of chronic leg ulcers resistant to standard therapy.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07048054
Sponsor's protocol ID
2024-00327
Acronym
RESCUE-PATCH
Status last verified
Jun 2025
First submitted
13 Jun 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TrophiPatch: allogeneic adipose-derived stromal cell patch in people with Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU), run by Nicolò Brembilla at 1 site in Switzerland.

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 19 inclusion and 28 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 2 Jul 2025. 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 Switzerland. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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 Nicolo C Brembilla, Dr (0041(0)22 3795751, nicolo.brembilla@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite safety outcome at week 12 from baseline (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07048054.

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 2 Jul 2025.

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