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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201203000367225 Date registered: 2012/02/29
TRIAL DESCRIPTION
Public title THE USE OF PHOTOTHERAPY AND PODIATRIC INTERVENTION TO MANAGE CHRONIC LOWER LIMB ULCERATIONS IN PATIENTS WITH TYPE II DIABETES MELLITUS: A PILOT STUDY
Official scientific title THE USE OF PHOTOTHERAPY AND PODIATRIC INTERVENTION TO MANAGE CHRONIC LOWER LIMB ULCERATIONS IN PATIENTS WITH TYPE II DIABETES MELLITUS: A PILOT STUDY
Brief summary describing the background
and objectives of the trial
Ulcers are a common complication in diabetes. In podiatry a dynamic management plan is required to treat diabetic lower limb ulcerations. Phototherapy is a therapeutic treatment modality which has been found to enhance wound healing. This study is a pilot study which aims to establish whether the application of phototherapy improves the rate of wound healing in chronic diabetic foot ulcers when combined with podiatric treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 2011-09-01
Actual trial start date 2011-09-12
Anticipated date of last follow up 2012-10-31
Actual date of last follow up
Anticipated target sample size (number of participants) 15   
Actual target sample size (number of participants) 7   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
AEC72/01-2011 University of Johannesburg, Faculty of Health Sciences, Academic Ethics

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Simple Randomisation using procedures: as participants join the study they are put into group 1, 2 or 3 Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group 1 twice a week 3 months or until ulcer/s healed ulcers are treated using standard podiatric interventions and recieve placebo laser therapy 5 Placebo
Experimental group group 2 twice a week 3 months or until ulcer/s heal ulcer/s are treated using standard podiatric interventions and recieve laser therapy 5
Experimental group group 3 twice a week 3 months or until ulcer/s healed ulcer/s are treated using standard podiatric interventions and both ulcers and lymph nodes behind the knee recieve laser therapy 5

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1) Type II diabetes with neuropathic or mixed (venous and arterial) ulcers, 2) lower extremity ulcer, 3) stable or worsening ulcer which has been present for a minimum of 4 weeks, 4) willingness to participate and commitment to the study, and 5) signed consent to participate in the study 1) Evidence of acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity, 2) presence of any of one or more medical conditions including renal, hepatic, hematologic, neurologic, or immune disease not related to diabetes, 3) presence of malignant disease (other than basal cell carcinoma) not in remission for more than 5 years, 4) use of oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents, 5) known infection with HIV or presence of AIDS, 6) use of other investigational drug or device within 30 days of recruitment into the study, and 7) other leg ulcers, such as ulcers due to decubiti or vasculitis 18 Years 100 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/10/10 Faculty of Health Sciences, Academic Ethics Committee
Ethics Committee Address
Street address City Postal code Country
37 Nind Street Johannesburg 2028 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Establishing whether phototherapy improves the rate of wound healing of diabetic lower limb ulcers in combination with podiatric management End of study
Secondary Outcome Establish if phototherapy of diabetic ulcers as well as lymph nodes speeds up the healing process End of study

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Podiatry Clinic 37 Nind Street Doornfontein 2028 South Africa
Podiatry Department, Charlotte Maxeke Johannesburg Academic Hospital Jubilee Road Parktown, Johannesburg 2193 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg 37 Nind Street Doornfontein 2028 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg 37 Nind Street Doornfontein 2028 South Africa University

COLLABORATORS
Name Street address City Postal code Country
CHARLOTTE MAXEKE JOHANNESBURG ACADEMIC HOSPITAL 5 Jubilee Rd, Parktown, Johannesburg 2193 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Prof Heidi Abrahamse habrahamse@uj.ac.za +27 11 559-6406 +27 11 559-6558
Street address City Postal code Country Position / Affiliation
Laser Research Centre, Room 2116 JOB, PO Box 17011 Doornfontein, Johannesburg 2028 South Africa HOD, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg
Role Name Email Phone Fax
Principal Investigator Mr Bahle Nteleki bbahlenteleki@yahoo.com 011 559-6406
Street address City Postal code Country Position / Affiliation
Laser Research Centre, Room 2116 JOB, PO Box 17011 Doornfontein, Johannesburg 2028 South Africa Student, Podiatry Department, Faculty of Health Sciences, University of Johannesburg
Role Name Email Phone Fax
Scientific Enquiries Dr Nicolette Houreld nhoureld@uj.ac.za +27 11 559-6406 +27 11 559-6558
Street address City Postal code Country Position / Affiliation
Laser Research Centre, Room 2116 JOB, PO Box 17011 Doornfontein, Johannesburg 2028 South Africa Senior Lecturer, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg
Role Name Email Phone Fax
Scientific Enquiries Mr Epharim Modimakwane emodimakwane@uj.ac.za +27 011 559-6593
Street address City Postal code Country Position / Affiliation
Podiatry, Room 2105, JOB, PO Box 17011 Doornfontein, Johannesburg 2028 South Africa Senior Lecturer, Podiatry Department, Faculty of Health Sciences, University of Johannesburg