Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Female or male patient aged ≥ 18
With diagnosis of diabetic or other chronic wound
Grade 1 or 2 wound on the Wagner Scale
Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
Patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days)
Patient has adequate (>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
Patient has activated platelet thromboplastin time (aPTT) of < 1.6x the mean normal reference interval at the time of the lipoharvest procedure and no contraindication to lipoharvest

Exclusion Criteria:

Typical Charcot's foot
Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound [bone erosion or disappearance of the cortical bone]) as determined by MRI
Clinical evidence of uncontrolled infection at the inclusion visit
Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
Subjects with cancerous or pre-cancerous lesions in the area to be treated
Patient with working activity who cannot be on sick-leave during the study period
Patient suffering from a psychiatric disorder not treated
Clinical evidence of gangrene on any part of the affected foot
Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
Pregnant or nursing females
Patient receiving dialysis for renal insufficiency or who have severe renal dysfunction
Patient who cannot have an off-loading method
Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this study
Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study