This research studies the effect thermotherapy as treatment of Old World CL which is not invasive, non-toxic, and the short treatment. While the current standard treatment comprise daily painful injections with antimonials,
The current standard treatment for Old World CL is based on daily painful injections with antimonials, which in Pakistan requires specialised care provided in secondary level care facilities. Apart from potential toxic side effects of these antimonials, the long treatment course, high cost and inconvenience, it may prevent patients from seeking care or completing treatment, especially women and children in the Pakistan context. Untreated cutaneous leishmaniasis may leave disfiguring scars leading to stigmatisation and (psycho) social problems. If the CL lesions/scars are located on joints they can cause problems in motion and lead to disability. At a public health level, patients with untreated CL lesions are a reservoir for further transmission of CL in the family and community. Thermotherapy is topical, not invasive, non-toxic, and the treatment duration is only 7 days, and therefore is expected to have major benefits for patients. Additional advantages are that the HECT-CL can be applied by lower level qualified health workers, and the costs are low (less than 3 USD) per re-usable heat pad), and therefore can be rolled out to peripheral health facilities, potentially having a major impact on access to treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
To evaluate the effectiveness, safety and feasibility of thermotherapy with the low cost Hand-held Exothermic Crystallization Thermotherapy pad in the treatment of cutaneous leishmaniasis in Quetta, Balochistan, Pakistan.
Mohtarma Shaheed Benazir Bhutto Hospital Quetta.
Quetta, Balochistan, Pakistan
Effectiveness of the HECT-CL treatment as assessed by
The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment
Time frame: 180 days
Possible adverse effect of the HECT-CL treatment will studied by
The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)
Time frame: 180 days
Ease of use of the HECT-CL treatment as assessed by
the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).
Time frame: 180 days
Acceptability of the HECT-CL treatment as assessed by
proportion of patients completing the treatment schedule in time (feasibility)
Time frame: 180 days
Inappropriateness of the HECT-CL treatment as assessed by
the percentage of patients (%) with lesions where HECT-CL cannot be used, (e.g. near eyes and lips, larger than 6 cm, or more than four lesions) (feasibility)
Time frame: 180 days
The scars remaining after the HECT-CL treatment as assessed by
the proportion of patients with remaining scars
Time frame: 180 days
The duration of the healing process as assessed by
The mean time (days) between time of start of treatment and complete re-epithelisation of the treated lesion the healing of the lesion (time-to-heal).
Time frame: 180 days
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