From:  Emerging targets and gene-based therapeutics in diabetic foot ulcer: a comprehensive review

 Gene therapies for diabetic foot ulcers (DFUs).

StudyAim of the study/strategyPatient populationOutcome
Schindler et al. [90]
Phase I, open-label, dose-finding study		Four cohorts of patients received AUP1602-C as a single dose of 2.5 × 105 colony-forming unit (CFU)/cm2 ulcer size or as repeated doses between 2.5 × 106 and 2.5 × 108 CFU/cm2 administered 3 times per week for 6 weeks.16 patients aged 53-80 years.AUP1602-C is safe and well-tolerated and showed dose-dependent efficacy in patients with DFU.
A dose of 2.5 × 108 CFU/cm2 showed complete healing in 83% of patients.
No recurrence in follow-up.
Perin et al. [89]
Phase 3 study		0.25 mg per 0.5 mL per injection via 16 injections (4 mg total per visit) of VM202, a plasmid DNA expressing two isoforms of human hepatocyte growth factor, into the ipsilateral calf of the affected foot on days 0, 14, 28, and 42.44 subjects with neuroischemic DFUs.Wound closure in the VM202 group occurred from 3 to 6 months, but with no statistical significance.
Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in promoting healing in chronic neuroischemic DFUs.
Kessler et al. [91]
Randomized, placebo-controlled phase III study		 To check the efficacy of VM202 in subjects with painful diabetic peripheral neuropathy.Part I: 9 months with 500 subjects. Part II: 101 subjects with a noninterventional extension to 12 months.VM202 failed to meet its efficacy endpoints in part I but showed significant and clinically meaningful pain reduction versus placebo in part II.
VM202 may attenuate disease progression.
Dewberry et al. [92]
Pre-clinical study		Cerium oxide nanoparticle conjugation to microRNA-146a.Diabetic mice model.Cerium oxide nanoparticle -microRNA-146a promotes wound healing.
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