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

NCT02169167 | Completed

• 1 other identifier: NKBBN/75/2014
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and ischemic etiology. Ulceration of lower limb is one of the most common complications related with diabetes and one of the major causes for hospitalization of diabetic patients. The most significant contributors to diabetic lower limb ulceration are neuropathy, deformity, uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease, male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous burden on health care resources worldwide, and at least 33% of all expenses are spent to treat diabetic ulcers manifested as a complication of diabetes. Although at least 170 topical wound care products are available, evidence of the superiority of one over another is tenuous, well-designed randomized, controlled trials are rare, and the number of case-control or observational studies is limited. In recent years, salve prepared from Norway spruce (Picea abies) resin has successfully been used in medical context to treat both acute and chronic wounds and ulcers of various origins. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of neuropathic diabetic foot ulcer in patients, who are suffering from infected fore- or mid-foot ulceration (PEDIS-classification ≥ Grade II; 19) originated from Type I or II diabetes, and in patients whose diabetic ulcerations are candidates for topical treatment with resin (Study treatment) or octenidine (Control treatment). In addition, factors contributing with delayed healing of ulceration, antimicrobial properties, safety and cost-effectiveness of the resin salve treatment and control treatment will be analyzed.

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; Wound Infection

Keywords

Diabetes complications; Diabetic foot; Foot ulcer; Wound healing; Wound infection

Outcome Measures

Primary Outcomes (1)

• Wound healing

  To scrutinize complete healing of neuropathic diabetic foot ulceration over time.

  Within 6 months

Secondary Outcomes (1)

• Eradication of bacteria

  Within six months

Other Outcomes (1)

• Wound healing and infection

  Within six months

Study Arms (2)

Resin salve treatment

EXPERIMENTAL

The resin salve may be spread directly onto the diabetic ulcer, after which the area is covered with a bandage suitable for local wound care. The bandage prohibits salve from moving away from the ulcer area. If the skin condition is more widespread or contains cavities or fistulae, the salve may be spread as a film with a thickness of at least 1 mm onto a gauze or gauze ribbon that is then used to fill the cavity or fistulae channel. Bandages are changed every 1-3 days, depending on the degree of infection and amount of ulcer secretion.

Device: Resin salve treatment

Octenidine treatment

ACTIVE COMPARATOR

Octenidine treatment is implemented with the similar manner as resin salve treatment by using sterile gauze that is impregnated with the octenidine dihydrochloride.

Device: Octenidine treatment

Interventions

Resin salve treatment DEVICE

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).

Also known as: Abilar 10% Resin Salve

Resin salve treatment

Octenidine treatment DEVICE

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.

Also known as: Octenisept

Octenidine treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• an adult patient (18-80 years) suffering from infected neuropathic fore- or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II).

You may not qualify if:

• a patient whose life expectancy is less than 6 months
• an ulceration of ischemic or neuroischemic origin
• presence of systemic inflammatory response signs
• heel ulceration
• presence of osteomyelitis
• pregnancy
• known hypersensitivity to any of the ingredient including in the study or control treatment products
• a patient who is unable to give informed consent
• a patient who has an advanced malignant disease.

Sponsors & Collaborators

• Janne J. Jokinen: lead
• Repolar Pharmaceuticals Oy: collaborator

Study Sites (1)

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

Gdansk, Gdańsk, 80-952, Poland

Location

Related Publications (16)

• Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999 Jan;22(1):157-62. doi: 10.2337/diacare.22.1.157.

  PMID: 10333919 BACKGROUND

• Frykberg RG. Diabetic foot ulcers: pathogenesis and management. Am Fam Physician. 2002 Nov 1;66(9):1655-62.

  PMID: 12449264 BACKGROUND

• Akbari CM, Macsata R, Smith BM, Sidawy AN. Overview of the diabetic foot. Semin Vasc Surg. 2003 Mar;16(1):3-11. doi: 10.1053/svas.2003.50001. No abstract available.

  PMID: 12644970 BACKGROUND

• Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.

  PMID: 17280936 BACKGROUND

• Driver VR, Fabbi M, Lavery LA, Gibbons G. The costs of diabetic foot: the economic case for the limb salvage team. J Vasc Surg. 2010 Sep;52(3 Suppl):17S-22S. doi: 10.1016/j.jvs.2010.06.003.

  PMID: 20804928 BACKGROUND

• Sipponen A, Jokinen JJ, Lohi J. Resin salve from the Norwegian spruce tree: a 'novel' method for the treatment of chronic wounds. J Wound Care. 2007 Feb;16(2):72-4. doi: 10.12968/jowc.2007.16.2.26999. No abstract available.

  PMID: 17319621 BACKGROUND

• Sipponen A, Jokinen JJ, Sipponen P, Papp A, Sarna S, Lohi J. Beneficial effect of resin salve in treatment of severe pressure ulcers: a prospective, randomized and controlled multicentre trial. Br J Dermatol. 2008 May;158(5):1055-62. doi: 10.1111/j.1365-2133.2008.08461.x. Epub 2008 Feb 16.

  PMID: 18284391 BACKGROUND

• Rautio M, Sipponen A, Peltola R, Lohi J, Jokinen JJ, Papp A, Carlson P, Sipponen P. Antibacterial effects of home-made resin salve from Norway spruce (Picea abies). APMIS. 2007 Apr;115(4):335-40. doi: 10.1111/j.1600-0463.2007.apm_548.x.

  PMID: 17504300 BACKGROUND

• Rautio M, Sipponen A, Lohi J, Lounatmaa K, Koukila-Kahkola P, Laitinen K. In vitro fungistatic effects of natural coniferous resin from Norway spruce (Picea abies). Eur J Clin Microbiol Infect Dis. 2012 Aug;31(8):1783-9. doi: 10.1007/s10096-011-1502-9. Epub 2011 Dec 17.

  PMID: 22179415 BACKGROUND

• Sipponen A, Laitinen K. Antimicrobial properties of natural coniferous rosin in the European Pharmacopoeia challenge test. APMIS. 2011 Oct;119(10):720-4. doi: 10.1111/j.1600-0463.2011.02791.x. Epub 2011 Jul 18.

  PMID: 21917009 BACKGROUND

• Sipponen A, Peltola R, Jokinen JJ, Laitinen K, Lohi J, Rautio M, Mannisto M, Sipponen P, Lounatmaa K. Effects of Norway spruce (Picea abies) resin on cell wall and cell membrane of Staphylococcus aureus. Ultrastruct Pathol. 2009;33(3):128-35. doi: 10.1080/01913120902889138.

  PMID: 19479653 BACKGROUND

• Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E. 2012 infectious diseases society of america clinical practice guideline for the diagnosis and treatment of diabetic foot infections. J Am Podiatr Med Assoc. 2013 Jan-Feb;103(1):2-7. doi: 10.7547/1030002.

  PMID: 23328846 BACKGROUND

• Brolmann FE, Ubbink DT, Nelson EA, Munte K, van der Horst CM, Vermeulen H. Evidence-based decisions for local and systemic wound care. Br J Surg. 2012 Sep;99(9):1172-83. doi: 10.1002/bjs.8810. Epub 2012 Jul 6.

  PMID: 22777856 BACKGROUND

• Hubner NO, Siebert J, Kramer A. Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds. Skin Pharmacol Physiol. 2010;23(5):244-58. doi: 10.1159/000314699. Epub 2010 May 18.

  PMID: 20484966 BACKGROUND

• Krishna BV, Gibb AP. Use of octenidine dihydrochloride in meticillin-resistant Staphylococcus aureus decolonisation regimens: a literature review. J Hosp Infect. 2010 Mar;74(3):199-203. doi: 10.1016/j.jhin.2009.08.022. Epub 2010 Jan 8.

  PMID: 20060619 BACKGROUND

• Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

  PMID: 11323066 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; Wound Infection; Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Infections; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases

Study Officials

• Janne J. Jokinen, MD, PhD

  Repolar Pharmaceuticals Oy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

PL (1)