Trial · NCT00884377
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
NCT00884377, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2017-07-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis. Trials, record NCT00884377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
- NCT number
- NCT00884377
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Cutaneous Leishmaniasis
- Interventions
- Sodium stibogluconate (Pentostam), ThermoMed
- First posted
- 2009-04-20
- Last updated
- 2020-01-02
- Results first posted
- 2017-07-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Assessment of cure is made at 2 months after treatment | Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. |
| Secondary | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | 12 months | Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. |
| Secondary | Number of Participants With Solicited Adverse Events | Days 3, 7 and 10 | To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events |
| Secondary | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | day 1 and day 10 | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. |
| Secondary | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | day 1 and day 10 | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. |
| Secondary | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | at baseline before treatment | Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Assessment of cure is made at 2 months after treatment | A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Solicited Adverse Events | Days 3, 7 and 10 | Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days. | subjects showing specified symptoms | NUMBER |
| SECONDARY | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | day 1 and day 10 | Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10 | populations of T-cells | MEAN |
| SECONDARY | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | day 1 and day 10 | Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10 | % of T-cells | MEAN |
| SECONDARY | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | at baseline before treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Sodium Stibogluconate | Healed | 22 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | ThermoMed Device | Healed | 18 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Sodium Stibogluconate | Not Healed | 5 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | ThermoMed Device | Not Healed | 9 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Sodium Stibogluconate | Not Applicable | 1 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | ThermoMed Device | Not Applicable | 1 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Sodium Stibogluconate | Cured | 13 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | ThermoMed Device | Cured | 11 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Sodium Stibogluconate | Not Cured | 13 | Participants | |
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | ThermoMed Device | Not Cured | 14 | Participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With IV Sodium Stibogluconate | 28 | |
| Overall Study | STARTED | Treatment With Thermomed Device | 28 | |
| Overall Study | COMPLETED | Treatment With IV Sodium Stibogluconate | 26 | |
| Overall Study | COMPLETED | Treatment With Thermomed Device | 27 | |
| Overall Study | NOT COMPLETED | Treatment With IV Sodium Stibogluconate | 2 | |
| Overall Study | NOT COMPLETED | Treatment With Thermomed Device | 1 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lesion site blister | Skin and subcutaneous tissue disorders | Sodium Stibogluconate Intravenous | 0 | 28 | 0 |
| other | Lesion site blister | Skin and subcutaneous tissue disorders | ThermoMed Device | 25 | 28 | 25 |
| other | No blanching with pressure | Vascular disorders | Sodium Stibogluconate Intravenous | 1 | 28 | 1 |
| other | No blanching with pressure | Vascular disorders | ThermoMed Device | 18 | 28 | 18 |
| other | Site erythema | Skin and subcutaneous tissue disorders | Sodium Stibogluconate Intravenous | 5 | 28 | 5 |
| other | Site erythema | Skin and subcutaneous tissue disorders | ThermoMed Device | 21 | 28 | 21 |
| other | Site eschar | Injury, poisoning and procedural complications | Sodium Stibogluconate Intravenous | 9 | 28 | 9 |
| other | Site eschar | Injury, poisoning and procedural complications | ThermoMed Device | 25 | 28 | 25 |
| other | Site infection | Infections and infestations | Sodium Stibogluconate Intravenous | 1 | 28 | 1 |
| other | Site infection | Infections and infestations | ThermoMed Device | 5 | 28 | 5 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Stibogluconate Intravenous | 0 | 28 |
| Total, all-cause mortality | ThermoMed Device | 0 | 28 |
| Total, other adverse events | Sodium Stibogluconate Intravenous | 28 | 28 |
| Total, other adverse events | ThermoMed Device | 28 | 28 |
| Total, serious adverse events | Sodium Stibogluconate Intravenous | 5 | 28 |
| Total, serious adverse events | ThermoMed Device | 2 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20231896 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sodium Stibogluconate Intravenous vs ThermoMed Device: deaths from any cause | Trial comparisons |
| Sodium Stibogluconate Intravenous vs ThermoMed Device: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00884377
GET https://conductscience.org/api/trials/v1/NCT00884377/results?page=2