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

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ClinicalTrials.gov Identifier: NCT02169167
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Repolar Ltd.
Information provided by (Responsible Party):
Janne J. Jokinen, Helsinki University Central Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes Complications Diabetic Neuropathies Wound Infection Device: Resin salve treatment Device: Octenidine treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Resin Salve and Conventional Octenidine in Patients With Neuropathic Diabetic Foot Ulcers - a Prospective, Randomized and Controlled Clinical Trial
Study Start Date : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resin salve treatment
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
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).
Other Name: Abilar 10% Resin Salve

Active Comparator: Octenidine treatment
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
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.
Other Name: Octenisept




Primary Outcome Measures :
  1. Wound healing [ Time Frame: Within 6 months ]
    To scrutinize complete healing of neuropathic diabetic foot ulceration over time.


Secondary Outcome Measures :
  1. Eradication of bacteria [ Time Frame: Within six months ]
    To analyze successful eradication rate of pathogenic bacteria from the ulcers within the study period as documented by negative swab culture.


Other Outcome Measures:
  1. Wound healing and infection [ Time Frame: Within six months ]
    To analyze the rate of ulcers with 50% decrease in ulcer size and disappearing of clinical signs of infection over time.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169167


Locations
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Poland
Diabetic Foot Clinic Regional Diabetic Centre, Department of Hypertension and Diabetology
Gdańsk, Poland, 80-952
Sponsors and Collaborators
Janne J. Jokinen
Repolar Ltd.
Investigators
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Study Chair: Janne J. Jokinen, MD, PhD Repolar Ltd.

Publications:

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Responsible Party: Janne J. Jokinen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02169167     History of Changes
Other Study ID Numbers: NKBBN/75/2014
NKBBN/75/2014 ( Other Identifier: Gdansk University Hospital )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Janne J. Jokinen, Helsinki University Central Hospital:
Diabetes complications
Diabetic foot
Foot ulcer
Wound healing
Wound infection
Additional relevant MeSH terms:
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Wound Infection
Diabetic Neuropathies
Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Foot Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Octenidine
Anti-Infective Agents
Anti-Infective Agents, Local