THE USE OF PHOTOTHERAPY AND PODIATRIC INTERVENTION TO MANAGE CHRONIC LOWER LIMB ULCERATIONS IN PATIENTS WITH TYPE II DIABETES MELLITUS: A PILOT STUDY

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201203000367225
• Date of registration: 29/02/2012
• Primary sponsor: University of Johannesburg
• 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
• 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
• Date of first enrolment: 2011-09-12
• Target sample size: 5
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201203000367225
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Heidi Abrahamse
• Affiliation: HOD, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg

• Name: Nicolette Houreld
• Affiliation: Senior Lecturer, Laser Research Centre, Faculty of Health Sciences, University of Johannesburg

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum: 18 Year
Age maximum: 100 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic

Primary Outcome(s)

Establishing whether phototherapy improves the rate of wound healing of diabetic lower limb ulcers in combination with podiatric management

Secondary Outcome(s)

Establish if phototherapy of diabetic ulcers as well as lymph nodes speeds up the healing process

Secondary ID(s)

AEC72/01-2011

Source(s) of Monetary Support

University of Johannesburg