Clinical trial on enzymatic agent Salizolis

ISRCTN ISRCTN32740751
DOI https://doi.org/10.1186/ISRCTN32740751
Secondary identifying numbers N/A
Submission date
09/11/2004
Registration date
08/12/2004
Last edited
03/03/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rimdeika Rytis
Scientific

Kaunas Medical University Hospital
Department of Surgery
Division of Plastic Surgery and Burns
Eiveniu str. 2
Kaunas
50009
Lithuania

+370 37 326083
rimdeika@kmu.lt

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSALIZOLIS
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedWounds
InterventionThe randomised and controlled, single blind and parallel group study will be carried out on two groups. Each group consists of 15 patients.
Patients of group A are being treated according to the current standards of therapy. The wounds will be self-purged out of necrotic tissues.
Patients of group B are being treated according to the new regimen under investigation - enzymatic agent Salizolis. Necrotic tissue of the wounds will be purged out by enzymatic agent.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Salizolis
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteriaPatients with acute and chronic wounds containing necrotic tissue (thermal and chemical burns, frostbites, trophic ulcers, injuries of truncal and limb, injuries of wrist and hand, injuries of tarsus and foot, varicosis of lower limbs with ulcers and inflammation, foot ulcers, pressure sores, infections on dermal and hypodermal tissue and other purulent inflammations).

Inclusion criteria:
1. Older than 18 years
Key exclusion criteria1. Children under the age of 18
2. Pregnant women
3. Soldiers of active service
4. Incurable patients
5. Patients with mental disorder
6. Patients dependent on drugs and alcohol
7. Subjects incapable of giving consent
8. Subjects disagree with participation in clinical trial
Date of first enrolment01/12/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Lithuania

Study participating centre

Kaunas Medical University Hospital
Kaunas
50009
Lithuania

Sponsor information

JSC Biocentras (Lithuania)
Industry

Graiciuno str. 10
Vilnius
02241
Lithuania

+370 5 2661313
biocentras@biocentras.lt
http://www.biocentras.lt/about_en.html
ROR logo https://ror.org/005gk6w44

Funders

Funder type

Government

Sixth framework programme horizontal research activities involving small and medium sized enterprises (SMEs) co-operative research project - Ultimate Pressure Dressing System for the Management of Venous Ulcers (European Union)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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