Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan (HECT-CL)
|ClinicalTrials.gov Identifier: NCT03208543|
Recruitment Status : Terminated (failure rate 91.1%)
First Posted : July 5, 2017
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniases||Device: HECT-CL||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||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|
|Actual Study Start Date :||October 4, 2017|
|Actual Primary Completion Date :||December 20, 2017|
|Actual Study Completion Date :||December 20, 2017|
HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)
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.
- Effectiveness of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment
- Possible adverse effect of the HECT-CL treatment will studied by [ Time Frame: 180 days ]The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)
- Ease of use of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).
- Acceptability of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]proportion of patients completing the treatment schedule in time (feasibility)
- Inappropriateness of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]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)
- The scars remaining after the HECT-CL treatment as assessed by [ Time Frame: 180 days ]the proportion of patients with remaining scars
- The duration of the healing process as assessed by [ Time Frame: 180 days ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208543
|Mohtarma Shaheed Benazir Bhutto Hospital Quetta.|
|Quetta, Baluchistan, Pakistan, 00000|
|Study Director:||Koert Ritmeijer, PhD||Medecins Sans Frontieres, Netherlands|