NCT01554644

Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

A Randomized, Double-Blind Exploratory Pilot Study Comparing Prontosan(TM) Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: B. Braun Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.

Conditions

• Diabetic Complications

Interventions

Type	Name	Description
DEVICE	Prontosan	Prontosan(TM) Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and Prontosan(TM) Wound Gel (PHMB 0.1%, Betaine 0.1%). Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.
DEVICE	Saline	Saline Wound Irrigation Solution and inert Wound Gel. Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-03-15
• Last updated: 2013-07-16

Locations

2 sites across 1 country: United States