Cutaneous LeishmaniasisHECTNCT01277796
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
A study testing Heat pack conduction-heat therapy in people with Cutaneous Leishmaniasis, run by Universidad Peruana Cayetano Heredia.
Trial summary
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Heat pack conduction-heat therapy
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
- aged 8-80 years old
- with no more than 3 lesions
- ulcerative and non-ulcerative ulcers less than 4 cm diameter.
- allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
- capable of signing an informed consent or having capable guardians (in the case of minors).
- Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.
Who cannot join
- lesions less than 2cm from the nose, mouth, ears, or eyes.
- clinically diagnosed with mucosal involvement.
- evidence of lymph node involvement on exam.
- unable or unwilling to commit to the treatment and follow-up plan.
- prior CL treatment within last 1 month.
- pregnant or lactating
- uncontrolled severe systemic illness or immunocompromised state.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Heat pack conduction-heat therapy
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat pack conduction-heat therapyDevice
Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University School of Medicine
- Investigators
- Alejandro Llanos-Cuentas, MD, PhD, Principal investigator, Universidad Peruana Cayetano HerediaWitzig Richard, MD, MPH, Principal investigator, Tulane Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277796
- Sponsor's protocol ID
- 032-08
- Acronym
- HECT
- Status last verified
- Jan 2011
- First submitted
- 13 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device
- ClinicalTrials.gov ID
- NCT01277796
- Acronym / sponsor ID
- HECT / 032-08
- Conditions
- Cutaneous Leishmaniasis
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Tulane University School of Medicine
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.
Study design
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
- aged 8-80 years old
- with no more than 3 lesions
- ulcerative and non-ulcerative ulcers less than 4 cm diameter.
- allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
Key exclusion criteria (7 listed)
- lesions less than 2cm from the nose, mouth, ears, or eyes.
- clinically diagnosed with mucosal involvement.
- evidence of lymph node involvement on exam.
- unable or unwilling to commit to the treatment and follow-up plan.
- prior CL treatment within last 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat pack conduction-heat therapyHand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Llanos-Cuentas, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
Witzig Richard, MD, MPH principal investigator
Tulane Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Heat pack conduction-heat therapy in people with Cutaneous Leishmaniasis, run by Universidad Peruana Cayetano Heredia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Llanos-Cuentas, MD, PhD (51-1-482-7739, elmer.llanos@upch.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.