Abstract
BackgroundA previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency (HF) electro-cauterization (EC) of cutaneous leishmaniasis (CL) ulcers and subsequent moist wound treatment (MWT) closed 85% of all Leishmania (L.) tropica lesions within 60 days.MethodsA three-armed phase IIb, randomized and controlled clinical trial was performed in Mazar-e-Sharif. L. tropica- or L. major-infected CL patients received intradermal sodium stibogluconate (SSG) (Group I); HF-EC followed by MWT with 0.045% DAC N-055 (Group II); or MWT with 0.045% DAC N-055 in basic crème alone (Group III). The primary outcome was complete epithelialisation before day 75 after treatment start.Results87 patients enrolled in the trial were randomized into group I (n = 24), II (n = 32) and III (n = 31). The per-protocol analysis of 69 (79%) patients revealed complete epithelialisation before day 75 in 15 (of 23; 65%) patients of Group I, in 23 (of 23; 100%) patients of Group II, and in 20 (of 23; 87%) patients of Group III (p = 0.004, Fisher’s Exact Test). In the per-protocol analysis, wound closure times were significantly different between all regimens in a pair-wise comparison (p = 0.000039, Log-Rank (Mantel-Cox) test). In the intention-to-treat analysis wound survival times in Group II were significantly different from those in Group I (p = 0.000040, Log-Rank (Mantel-Cox) test). Re-ulcerations occurred in four (17%), three (13%) and seven (30%) patients of Group I, II or III, respectively (p = 0.312, Pearson Chi-Square Test).ConclusionsTreatment of CL ulcers with bipolar HF-EC followed by MWT with 0.045% DAC N-055 or with DAC N-055 alone showed shorter wound closure times than with the standard SSG therapy. The results merit further exploration in larger trials in the light of our current knowledge of in vitro and in vivo activities of chlorite. Clinicaltrials.gov ID: NCT00996463. Registered: 15th October 2009.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0619-8) contains supplementary material, which is available to authorized users.
Highlights
A previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency (HF) electro-cauterization (EC) of cutaneous leishmaniasis (CL) ulcers and subsequent moist wound treatment (MWT) closed 85% of all Leishmania (L.) tropica lesions within 60 days
In 1986, a randomized controlled trial (RCT) has shown that moist dressing with a sodium chlorite (NaClO2)based drug is beneficial for rapid wound cleansing and granulation [3]
If not further concentrated under vacuum, pharmaceutical chlorite contains a chlorine peroxide contaminant, formerly called tetradecachlorooxygen (TCDO), a chemical name refuted by the German Health Authorities [4]
Summary
A previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency (HF) electro-cauterization (EC) of cutaneous leishmaniasis (CL) ulcers and subsequent moist wound treatment (MWT) closed 85% of all Leishmania (L.) tropica lesions within 60 days. In Afghanistan, cutaneous leishmaniasis (CL) ulcers resulting from parasite infections disfigure non-covered parts of the body especially at younger age. In 1986, a randomized controlled trial (RCT) has shown that moist dressing with a sodium chlorite (NaClO2)based drug is beneficial for rapid wound cleansing and granulation [3]. If not further concentrated under vacuum (which is commonly practiced with industrial NaClO2), pharmaceutical chlorite contains a chlorine peroxide contaminant, formerly called tetradecachlorooxygen (TCDO), a chemical name refuted by the German Health Authorities [4]. In animal experiments with non-thermal (NTP) [10] or cold atmospheric plasma (CAP) [11] lower μM levels 1O2 have shown to induce wound healing
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