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

Diabetic Ulcer Clinical Trial

Official title:

Diabetic Foot Ulcers and Use of PDRN (Polydeoxyribonucleotide -Placentex Mastelli) as a Treatment for Wound Healing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638872
• Other study ID #: PLA/01/06
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2008
• Last updated: September 10, 2012
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Ulcer
• Foot Ulcer
• Foot Ulcer Unhealed
• Ulcer

Intervention

Drug:
• Polydeoxyribonucleotide
3 times a week perilesional or intramuscular injections

Other:
• 0.9% NaCl
same as PDRN

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of ulcer rate		3 months	No
Secondary	safety and tolerability of the compound		6 months	Yes