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CTRI Number  CTRI/2013/05/003687 [Registered on: 27/05/2013] Trial Registered Retrospectively
Last Modified On: 24/05/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Soft Corns by Cryotherapy 
Scientific Title of Study   Cryotherapy as a treatment modality for Soft Corns: An open label clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nelee Bisen 
Designation  Senior Resident 
Affiliation  Father Muller Medical College 
Address  Dermatology OPD, Father Muller Medical College, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9141502838  
Fax    
Email  drnelee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Bhat M 
Designation  Professor and Head of the Department 
Affiliation  Father Muller Medical College 
Address  Dermatology OPD, Father Muller Medical College, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  0824-2238261  
Fax    
Email  rameshderma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nelee Bisen 
Designation  Senior Resident 
Affiliation   
Address  Dermatology OPD, Father Muller Medical College, Kankanady, Mangalore


KARNATAKA
575002
India 
Phone  9141502838  
Fax    
Email  drnelee@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nelee Bisen  Dermatology OPD  Room no.35, Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA 
9141502838

drnelee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Soft corns,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liquid Nitrogen Cryotherapy - spray technique   Two 15- to 20-second freeze-thaw cycles will be given in each treatment session. Four such sessions will be given at an interval of 2 weeks each.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients coming to Dermatology OPD, Father Muller Medical College and Hospital, Mangalore with clinical diagnosis of Soft corns
Inclusion criteria-
•Age more than 18 years
•Patients willing to undergo cryotherapy 
 
ExclusionCriteria 
Details  Exclusion criteria-
•Patients with Diabetes mellitus and Peripheral vascular disease
•Uncooperative patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Disappearance/Reduction in corn size  Two months 
 
Secondary Outcome  
Outcome  TimePoints 
Total number of patients showing improvement  Three months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/03/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION / NEED FOR STUDY:

Corns are painful, hyperkeratotic lesions of the skin that develop in response to excess pressure on the bony prominences of the feet and toes. They are often seen in athletes and in patient populations exposed to uneven friction from footwear or gait abnormalities, including elderly persons, diabetic patients, and amputees.1 Pathogenesis involves hyperplasia of the epidermis particularly stratum corneum, resulting from mechanical trauma to the skin. Various clinical types of corns include hard, soft, seed, periungual, neurofibrous and neurovascular. The hard corn, which is the most common type, appears as a dry, horny mass of hyperkeratosis with a hard central core. The soft corn results from the absorption of moisture from perspiration and is noted by its characteristic macerated appearance. Its an extremely painful lesion that can develop between any of the toes but most commonly develops between the fourth and fifth toes.

The various treatment options for relief of symptoms in corns include regular paring, use of keratolytics like salicylic acid, use of properly fitting footwear and better foot hygiene. However, soft corns are often difficult to treat.  Applying an antifungal or antibacterial powder and using a toe spacer are additional techniques used to treat soft corns. But results are often unsatisfactory.

Cryotherapy, also known as cryosurgery, is a commonly used in-office procedure for the treatment of a variety of benign and malignant lesions like keloids, viral warts, seborrheic keratosis, actinic keratosis, bowen’s disease, corns and calluses etc. The mechanism of action in cryotherapy can be divided into 3 phases: (1) heat transfer, (2) cell injury, and (3) inflammation. When using the spray cryotherapy technique, the liquid nitrogen is applied directly on the skin, and evaporation (boiling heat transfer) occurs in which the heat in the skin is quickly transferred to the liquid nitrogen. Cell injury occurs during the thaw, after the cell is frozen. The transformation of water to ice concentrates the extracellular solutes and results in an osmotic gradient across the cell membrane, causing further damage. Inflammation is the response to cell death and helps in local cell destruction. By virtue of its property to cause keratinocyte cell death and epidermal sloughing, cryotherapy potentially has a role in the treatment of soft corns.

Very few studies have been conducted to assess the efficacy of various treatment modalities in patients with corns. Recently Akdemir O et al found that tangential excision together with topical cantharidin was a simple, minimally invasive and reliable treatment for calluses and corns.  Although prevalence data in India is not available,  Indian population is more prone to develop corns due to prolonged engagement in wet work, habit of walking bare foot and poor maintenance of  foot hygiene. Till date, there is no published data on corn treatment in Indian context. Hence, we take up this study to find the role of cryotherapy in treating soft corns.

 

AIMS

To assess the efficacy of liquid nitrogen cryotherapy in the treatment of soft corns.

 

MATERIALS AND METHODS

Source of data collection

Patients coming to Dermatology OPD, Father Muller Medical College and Hospital, Mangalore with clinical diagnosis of Soft corns

Inclusion criteria-

•Age more than 18 years

•Patients willing to undergo cryotherapy

Exclusion criteria-

•Patients with Diabetes mellitus and Peripheral vascular disease

•Uncooperative patients

Method of data collection

Informed consent will be taken from all patients.

Detailed history taking and clinical examination will be done for each patient and information entered in a proforma.  Cryotherapy will be given with liquid nitrogen spray technique using a spray gun. Two 15- to 20-second freeze-thaw cycles will be given in each treatment session. Four such sessions will be given at an interval of 2 weeks each and any change in the lesions will be noted. Patients will be followed up for 1 month after the last treatment. Patients with secondary fungal or bacterial infection will be treated appropriately before starting cryotherapy.

Sample size

32 (Calculated based on a pilot study comprising of 5 patients)

Study period

One year

 
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