TrophiPatch cell patch for chronic diabetic and venous leg ulcers

Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* Subject has a history of:

  * endstage renal disease
  * uncontrolled cardiac failure
  * severe malnutrition
  * severe liver disease
  * aplastic anemia
  * 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.