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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-04

Study Completion Date

2017-12-20

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,

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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.

Conditions

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Cutaneous Leishmaniases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HECT-CL

HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)

Group Type EXPERIMENTAL

HECT-CL

Intervention Type DEVICE

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.

Interventions

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HECT-CL

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.

Intervention Type DEVICE

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes