Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan

Study Overview
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Brief Summary
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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,

Detailed Description
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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.

Official Title
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Effectiveness, Safety and Feasibility of Thermotherapy With the Hand-held Exothermic Crystallization Thermotherapy for Cutaneous Leishmaniasis (HECT-CL), Device for Cutaneous Leishmaniasis in Quetta, Pakistan

Conditions
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Cutaneous Leishmaniases

Intervention / Treatment
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* Device: HECT-CL


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with clinical CL symptoms for less than 6 months with the diagnosis confirmed by microscopic visualisation of Leishmania parasites in skin scrape smear. Patients who have given written informed consent. Exclusion criteria Patients presenting with CL lesions located on or within two centimetres of eyes and lips. Patients with more than four lesions. Lesions, nodules and/or ulcerations with a diameter (ø) of more than 6 cm. Patients with persistent lesions for more than 6 months. Patients younger than 10 years. Patients who are unlikely, unable or unwilling to be available for and comply to regular follow up visits for 6 months. Pregnant, and lactating women <6 months after delivery. Patients with uncontrolled medical illnesses. Patients with immune disorders, such as HIV/AIDS, or those who are on steroid medication

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients meeting inclusion criteria will be enrolled to receive seven treatment sessions with thermotherapy (HECT-CL device) and will be reassessed during follow up visits at day 15, 30, 60, 90 and 180
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HECT-CL<br>HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days) | Device: HECT-CL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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). | 180 days | 
| Acceptability of the HECT-CL treatment as assessed by | proportion of patients completing the treatment schedule in time (feasibility) | 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) | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The scars remaining after the HECT-CL treatment as assessed by | the proportion of patients with remaining scars | 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). | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pakistan, thermotherapy