Diabetes MellitusNCT02169167
Comparison of Resin Salve and Octenidine in Patients With Neuropathic Diabetic Foot Ulcers
A study testing Resin salve treatment and Octenidine treatment in people with Diabetes Mellitus and Diabetes Complications, run by Janne J. Jokinen at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Complications, Diabetic Neuropathies
- What is being tested?
- Resin salve treatment and Octenidine treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Diabetic Foot Clinic Regional Diabetic Centre, Department of Hypertension and Diabetology
Gdansk, Gdańsk, 80-952
About this study
Official title: Comparison of Resin Salve and Conventional Octenidine in Patients With Neuropathic Diabetic Foot Ulcers - a Prospective, Randomized and Controlled Clinical Trial
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.
Read the detailed description
PRIMARY OBJECTIVES
Primary objectives are:
- to scrutinize complete healing of neuropathic diabetic foot ulceration over time.
- to analyze successful eradication rate of pathogenic bacteria from the ulcers within the study period as documented by negative swab culture.
- to analyze the rate of ulcers with 50% decrease in ulcer size and disappearing of clinical signs of infection over time.
SECONDARY OBJECTIVES
Secondary objectives are:
- to assess potential contributors to delayed ulcer healing.
- to study the safety and compliance related with the treatment methods.
- to estimate the overall costs of the ulcer treatment with the resin salve treatment or octenidine treatment.
INCLUSION AND EXCLUSION CRITERIA
Inclusion criteria are:
- an adult patient (18-80 years) with infected neuropathic foot ulceration due to type I or II diabetes.
- PEDIS-classification ≥ Grade II.
Exclusion criteria are:
- 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.
METHODS Patient selection Altogether 40 adult patients (18 - 80 years) suffering from infected neuropathic fore- or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II) are randomly allocated into two groups (n = 20 patients / group) to receive either topical resin salve treatment or topical octenidine treatment for an appropriate diabetic ulceration. The patients who are recruited to the current study, are selected by the physicians, who are specialized in the treatment of diabetes and its complications. Treatment is commenced and followed-up at the outpatient clinic of the Diabetic Foot Clinic Regional Diabetic Centre, Department of Hypertension and Diabetology, Gdansk, Poland. Informed consent will be obtained from all patients.
FOLLOW-UP Demographics, clinically relevant medical, and follow-up data is gathered on the Clinical Report Form (CRF) by the responsible physicians for every patient at the beginning of the study, and within the every visit at the Diabetic Foot Clinic of the Regional Diabetic Centre until the study ends at six months later, at last. Thus, all recruited patients visit at the Diabetic Foot Clinic: 1. in the beginning of the study, and at 1, 2, 3, and 4 week time-points thereafter. After that, consecutive visit for every 3 to 4 weeks are arranged until the ends after the 6 months from the initiation. If the patient's clinical situation requires more frequent visits at the Diabetic Foot Clinic, those are arranged on the basis of the decision of research physician.
If the ulcer healing takes less than 6 months, the last follow-up information on the CRF is filled when the ulcer is considered being fully healed (primary objective is achieved). If the ulcer is not fully healed in 6 months, the treatment is considered unsuccessful, and follow-up is discontinued (primary objective is not achieved). Photographs are taken within every control visit at the outpatient department. Any notable improvement, deterioration, or any factor that might contribute with the ulcer healing during the follow-up, e.g. mechanical / surgical ulcer revision, cleansing, or antibiotic treatment will be registered on the CRF: Thus, CRF includes the details of:
- size of the ulcer [width (mm) x length (mm) x depth (mm)].
- signs of infection.
- swab culture.
- plain x-ray.
- erythrocyte sedimentation rate (ESR).
- C-reactive protein (CRP).
- full blood count.
- photographs with an appropriate measure.
- use of antibiotics.
- rate of dressing changes.
- potential side-effects (i.e. signs of hypersensitivity or allergic reaction).
- the use of off-loading shoe, and any specific notes or observations during the treatment period.
SAFETY ISSUES Hypersensitivity or allergy for resin or control treatment is taken into account, and if any symptoms of allergic reactions i.e. contact dermatitis appear, the study is discontinued for this particular patient.
- Being tested
- Resin salve treatment, Octenidine treatment
- Keywords
- Diabetes complications, Diabetic foot, Foot ulcer, Wound healing, Wound infection
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Diabetic Neuropathies, Wound Infection, Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin salve treatmentDevice
Also called Abilar 10% Resin Salve
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).
Octenidine treatmentDevice
Also called Octenisept
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Octenidine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
To scrutinize complete healing of neuropathic diabetic foot ulceration over time.
Measured: Within 6 months
Secondary outcomes (1)
Eradication of bacteria
To analyze successful eradication rate of pathogenic bacteria from the ulcers within the study period as documented by negative swab culture.
Measured: Within six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janne J. Jokinen
- Sponsor type
- University, hospital or other
- Collaborators
- Repolar Pharmaceuticals Oy
- Responsible party
- Sponsor-investigator, Janne J. Jokinen, Helsinki University Central Hospital
- Investigators
- Janne J. Jokinen, MD, PhD, Study chair, Repolar Pharmaceuticals Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169167
- Sponsor's protocol ID
- NKBBN/75/2014
- Other IDs
- NKBBN/75/2014
- Status last verified
- May 2015
- First submitted
- 19 Jun 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10333919Frykberg RG. Diabetic foot ulcers: pathogenesis and management. Am Fam Physician. 2002 Nov 1;66(9):1655-62.
PubMed 12449264Akbari 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.
PubMed 12644970Frykberg 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.
PubMed 17280936Driver 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.
PubMed 20804928Sipponen 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.
PubMed 17319621Sipponen 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.
PubMed 18284391Rautio 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.
PubMed 17504300Rautio 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.
PubMed 22179415Sipponen 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.
PubMed 21917009Sipponen 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.
PubMed 19479653Lipsky 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.
PubMed 23328846Brolmann 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.
PubMed 22777856Hubner 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.
PubMed 20484966Krishna 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.
PubMed 20060619
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Resin Salve and Conventional Octenidine in Patients With Neuropathic Diabetic Foot Ulcers - a Prospective, Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02169167
- Acronym / sponsor ID
- NKBBN/75/2014
- Keywords
- Diabetes complications, Diabetic foot, Foot ulcer, Wound healing, Wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Janne J. JokinenUniversity, hospital or other
- Collaborators
- Repolar Pharmaceuticals Oy
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES
Primary objectives are:
- to scrutinize complete healing of neuropathic diabetic foot ulceration over time.
- to analyze successful eradication rate of pathogenic bacteria from the ulcers within the study period as documented by negative swab culture.
- to analyze the rate of ulcers with 50% decrease in ulcer size and disappearing of clinical signs of infection over time.
SECONDARY OBJECTIVES
Secondary objectives are:
- to assess potential contributors to delayed ulcer healing.
- to study the safety and compliance related with the treatment methods.
- to estimate the overall costs of the ulcer treatment with the resin salve treatment or octenidine treatment.
INCLUSION AND EXCLUSION CRITERIA
Inclusion criteria are:
- an adult patient (18-80 years) with infected neuropathic foot ulceration due to type I or II diabetes.
- PEDIS-classification ≥ Grade II.
Exclusion criteria are:
- 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.
METHODS Patient selection Altogether 40 adult patients (18 - 80 years) suffering from infected neuropathic fore- or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II) are randomly allocated into two groups (n = 20 patients / group) to receive either topical resin salve treatment or topical octenidine treatment for an appropriate diabetic ulceration. The patients who are recruited to the current study, are selected by the physicians, who are specialized in the treatment of diabetes and its complications. Treatment is commenced and followed-up at the outpatient clinic of the Diabetic Foot Clinic Regional Diabetic Centre, Department of Hypertension and Diabetology, Gdansk, Poland. Informed consent will be obtained from all patients.
FOLLOW-UP Demographics, clinically relevant medical, and follow-up data is gathered on the Clinical Report Form (CRF) by the responsible physicians for every patient at the beginning of the study, and within the every visit at the Diabetic Foot Clinic of the Regional Diabetic Centre until the study ends at six months later, at last. Thus, all recruited patients visit at the Diabetic Foot Clinic: 1. in the beginning of the study, and at 1, 2, 3, and 4 week time-points thereafter. After that, consecutive visit for every 3 to 4 weeks are arranged until the ends after the 6 months from the initiation. If the patient's clinical situation requires more frequent visits at the Diabetic Foot Clinic, those are arranged on the basis of the decision of research physician.
If the ulcer healing takes less than 6 months, the last follow-up information on the CRF is filled when the ulcer is considered being fully healed (primary objective is achieved). If the ulcer is not fully healed in 6 months, the treatment is considered unsuccessful, and follow-up is discontinued (primary objective is not achieved). Photographs are taken within every control visit at the outpatient department. Any notable improvement, deterioration, or any factor that might contribute with the ulcer healing during the follow-up, e.g. mechanical / surgical ulcer revision, cleansing, or antibiotic treatment will be registered on the CRF: Thus, CRF includes the details of:
- size of the ulcer [width (mm) x length (mm) x depth (mm)].
- signs of infection.
- swab culture.
- plain x-ray.
- erythrocyte sedimentation rate (ESR).
- C-reactive protein (CRP).
- full blood count.
- photographs with an appropriate measure.
- use of antibiotics.
- rate of dressing changes.
- potential side-effects (i.e. signs of hypersensitivity or allergic reaction).
- the use of off-loading shoe, and any specific notes or observations during the treatment period.
SAFETY ISSUES Hypersensitivity or allergy for resin or control treatment is taken into account, and if any symptoms of allergic reactions i.e. contact dermatitis appear, the study is discontinued for this particular patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin salve treatment | Experimental | Device: Resin salve treatmentThe 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. |
| Octenidine treatment | Active comparator | Device: Octenidine treatmentOctenidine treatment is implemented with the similar manner as resin salve treatment by using sterile gauze that is impregnated with the octenidine dihydrochloride. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin salve treatmentAlso: Abilar 10% Resin SalveResin 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 | Resin salve treatment |
| Octenidine treatmentAlso: OcteniseptOctenidine 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. | Device | Octenidine treatment |
Primary outcome
Wound healing
Time frame: Within 6 months
To scrutinize complete healing of neuropathic diabetic foot ulceration over time.
1 secondary outcome
Eradication of bacteria
Time frame: Within six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 10333919Reiber 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.
- Background: PubMed 12449264Frykberg RG. Diabetic foot ulcers: pathogenesis and management. Am Fam Physician. 2002 Nov 1;66(9):1655-62.
- Background: PubMed 12644970Akbari 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.
- Background: PubMed 17280936Frykberg 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.
- Background: PubMed 20804928Driver 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.
- Background: PubMed 17319621Sipponen 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.
- Background: PubMed 18284391Sipponen 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.
- Background: PubMed 17504300Rautio 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.
- Background: PubMed 22179415Rautio 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.
- Background: PubMed 21917009Sipponen 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.
- Background: PubMed 19479653Sipponen 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.
- Background: PubMed 23328846Lipsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne J. Jokinen, MD, PhD study chair
Repolar Pharmaceuticals Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin salve treatment and Octenidine treatment in people with Diabetes Mellitus and Diabetes Complications, run by Janne J. Jokinen at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: Within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02169167, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.