Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers

University of Messina

Status and phase: Completed; Phase 4

Conditions: Foot Ulcer Unhealed; Diabetic Ulcer

Treatments: Other: 0.9% NaCl; Drug: Polydeoxyribonucleotide

Study type: Interventional

Funder types: Other

Identifiers

NCT00638872

PLA/01/06

Details and patient eligibility

About

The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

PDRN

Treatment:

Drug: Polydeoxyribonucleotide

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: 0.9% NaCl