(LML) Protocol for a Randomized Controlled Trial Investigating Decompression for Leprous Neuropathy (The DELN Protocol)

Leprosy Mailing List – November 8,  2016

Ref.: (LML)    Protocol for a Randomized Controlled Trial Investigating Decompression for Leprous Neuropathy (The DELN Protocol)

From:  Eric L Wan, Baltimore, USA

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Dear Dr. Schreuder,

 

 

The recent publication in Leprosy Review entitled "Protocol for a Randomized Controlled Trial Investigating Decompression for Leprous Neuropathy (The DELN Protocol)" is the result of significant effort on the part of Hansen's community members in 6 nations so far. The purpose of this email is to open discussion regarding our publication in Leprosy Review.

 

During the First Planning Meeting held in Denver, Colorado, USA in November 2015, surgeons, scientists, and clinicians exchanged knowledge about leprous neuropathy. Given the limitations of prior trials, as highlighted by Van Veen¹, it was agreed upon that a new randomized controlled trial (RCT) was necessary to evaluate the efficacy of surgical nerve decompression for leprous neuropathy. In our recent publication in Leprosy Review, we outlined major aspects of the RCT called the Decompression for Leprous Neuropathy (DELN) RCT. A full protocol of the DELN RCT is being drafted among the initial group of attendees at the First Planning Meeting and with consultation from the Institute for Clinical and Translational Research at the Johns Hopkins Bloomberg School of Public Health. We will be happy to include experts in the Hansen's community in this process.

 

Following the drafting of the DELN RCT protocol, we will be working with institutional review boards (IRBs) at multiple participating institutions and with potential funding sources, including the Leprosy Research Initiative, to further revise the protocol. Subsequently, the protocol will be submitted for funding and opened to the broader Hansen's community for comments. Currently, coordination will be provided by Eric Wan, BS, at the Johns Hopkins School of Medicine Department of Plastic and Reconstructive Surgery in Baltimore, Maryland, USA.

 

The first submission for IRB review will occur at the Johns Hopkins Medical Institutes (JHMI) in Baltimore. IRB approval at the JHMI will be dependent on a protocol agreed upon by the IRBs of all participating institutions. Therefore, following IRB submission at the JHMI, all participating institutions will be required to submit the DELN RCT protocol for IRB review. Throughout this process, participating parties including potential funding sources will be consulted as appropriate.

 

We are actively looking for comments on the published article. Additionally, if your institution would like to participate in this endeavor, or if you are a funding organization interested in this endeavor, please email the LML or Eric Wan at ewan1[at]jhmi[dot]com. We look forward to the ensuing discussion about our endeavor.

 

With warm regards,

[All the authors]

 

CC:

Leprosy Research Initiative

Gedge D. Rosson, MD

Carisa M. Cooney, MPH

James Wilton, DPM

William B. Ericson, MD

 

References
1.         Van Veen NH, Schreuders TA, Theuvenet WJ, Agrawal A, Richardus JH. Decompressive surgery for treating nerve damage in leprosy. Cochrane Database Syst Rev 2012;12:CD006983.

 

 

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LML - S Deepak, B Naafs, S Noto and P Schreuder

LML blog link: http://leprosymailinglist.blogspot.it/

Contact: Dr Pieter Schreuder << editorlml@gmail.com

 

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