Diabetic Ulcer, Foot Ulcer Unhealed
Conditions
Keywords
diabetes, foot ulcer, polydeoxyribonucleotide
Brief summary
The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.
Detailed description
This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.
Interventions
3 times a week perilesional or intramuscular injections
OTHER0.9% NaCl
same as PDRN
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 45-80yrs * Minimum schooling 5yrs * Type I or II diabetes since at least 5yrs with a stable metabolic control * Foot ulcer since minimum 2 weeks * Ulcer \>1cm and \<16cm at day 0 * Ulcer grade 1 or 2 wagner scale * Wound free of necrotic debris * TcPO2 \>29mmHg * Not pregnant or lactant
Exclusion criteria
* Non-consenting patient * History of alcohol or drug abuse * Gangrene on any part of the affected foot * Ongoing untreated infections * Ulcer over a charcot deformity * Use of a systemic cicatrizant drug in the past 10 days * Malnutrition * Neurological or psychiatric pathologies * Liver or kidney insufficiency * Corticosteroid or immunosuppressive or cytotoxic therapy * Other severe pathologies * Proven hypersensitivity to the drug or to any related component
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of ulcer rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability of the compound | 6 months |
Countries
Italy
Outcome results
None listed