Stempeutics Research Pvt. Ltd.

Diabetic Foot Ulcer - Medical / Health Care - Clinical Services

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Anti-inflammatory, angiogenic and wound healing properties of MSCs are key to successfully treat patients with DFU

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Diabetes is India`s fastest growing disease. About 77 million cases overall, the number is expected to reach 93 million by 2030. Approximately 15% of all Diabetic patients get foot problems - about 15 million. 60% of in-patient admissions in Diabetes are for foot problems and many patients end up with amputation. Only about 24% of wounds heal after 12 weeks of therapy. It has been estimated that every 30 seconds a lower limb is amputated due to the complications of Diabetes.

Debridement
Debridement should be carried out in all chronic wounds to remove surface debris and necrotic tissues.

Off-loading
Off-loading of the ulcer area is extremely important for the healing of plantar ulcers.

Dressings
Ulcers heal more quickly and are often less complicated by infection when in a moist environment.

Bioengineered Skin Substitutes
Accumulating evidence shows that bioengineered skin substitutes may be a promising therapeutic adjunct therapy to standard wound care.

MMP Modulators
Matrix metalloproteinases regulate the extracellular matrix components.

The management of DFU remains a major therapeutic challenge which implies an urgent need to review strategies and treatments.

Primary Efficacy Endpoints
  • Proportion of patients with complete healing / closure of the target ulcer at any time during the 12 week treatment period with sustained complete closure for 12 additional weeks of follow-up (Time frame: 12+12= 24 weeks)
  • Rate of reduction in size of the target ulcer
Secondary Efficacy End Points
  • Proportion of patients with at least 50% closure of target ulcer during the 24 weeks period
  • Proportion of patients with complete healing / closure of the target ulcer at any time during the 24 week follow up period

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