Comparison of Resin Salve and Octenidine in Patients With Neuropathic Diabetic Foot Ulcers

NACompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Diabetes MellitusDiabetes ComplicationsDiabetic NeuropathiesWound Infection
Interventions
DEVICE

Resin salve treatment

Resin is collected in the municipality of Kolari, Finland, from the trunks of full-grown Norway spruce (Picea acies) trees. Bark and other impurities are removed mechanically. The resin is then liquefied and purified by filtering. Resin salve is composed of a 10% (w/w) mixture of purified spruce resin in a standardized salve base. None of the components of the salve base have antibacterial properties. Resin salve is produced from the pure resin to the final product in accordance with the Good Manufacturing Standards (GMP) and it holds the European CE mark (Abilar 10% Resin Salve, Repolar Ltd., Espoo, Finland, CE 0537).

DEVICE

Octenidine treatment

Octenidine dihydrochloride is a cationic surfactant and bis-(dihydropyridinyl)-decane derivative, used in concentrations of 0.1-2.0%. It is similar in its action to the quaternary ammonium compounds, but is of somewhat broader spectrum of activity. Octenidine is currently increasingly used in continental Europe as a substitute for quats or chlorhexidine (with respect to its slow action and concerns about the carcinogenic impurity 4-chloroaniline) in water- or alcohol-based skin, mucosa and wound antiseptics. In aqueous formulations, it is often potentiated with addition of 2-phenoxyethanol.

Trial Locations (1)

80-952

Diabetic Foot Clinic Regional Diabetic Centre, Department of Hypertension and Diabetology, Gdansk

All Listed Sponsors
collaborator

Repolar Pharmaceuticals Oy

INDUSTRY

lead

Janne J. Jokinen

OTHER

NCT02169167 - Comparison of Resin Salve and Octenidine in Patients With Neuropathic Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter