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CTRI Number  CTRI/2024/12/077665 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Surgical Debridement and Therapeutic Use of Maggots in Diabetic Foot Ulcer 
Scientific Title of Study   AN OPEN LABEL CONTROLLED RANDOMISED CLINICAL STUDY TO EVALUATE EFFECT OF SURGICAL DEBRIDEMENT AND MAGGOT DEBRIDEMENT IN KAPHAJA DUSTA VRANA VIS-À-VIS DIABETIC FOOT ULCER  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasann Patreppa Hanji 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital Mysuru 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra.JSS Ayurveda Medical college and Hospital,#41/E,Lalithadripura road,Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9900802062  
Fax  08212548360  
Email  prasannhanji@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAiyanna PP 
Designation  Associate Professor 
Affiliation  JSS Ayurveda Medical college and Hospital 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra.JSS Ayurveda Medical college and Hospital,#41/E,Lalithadripura road,Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9738460501  
Fax  08212548360  
Email  draiyanna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasann Patreppa Hanji 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical college and Hospital 
Address  Room no.10 Department of PG and Ph.D studies in Shalya Tantra.JSS Ayurveda Medical college and Hospital,#41/E,Lalithadripura road,Mysuru-570028

Mysore
KARNATAKA
570028
India 
Phone  9900802062  
Fax  08212548360  
Email  prasannhanji@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital.Lalithadripura road.Mysuru.karnataka.India.570028 
 
Primary Sponsor  
Name  DR PRASANN PATREPPA HANJI 
Address  Room No.10 Department of PG And Ph.D Studies in Shalyatantra.JSS Ayurveda Medical College and Hospital,#41/E,Lalithadripura road,Mysuru-570028. 
Type of Sponsor  Other [self] 
 
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 
DR PRASANN PATREPPA HANJI  JSS Ayurveda Medical College and Hospiotal  Room no.10 Department of PG and Ph.D studies in Shalya Tantra.JSS Ayurveda Medical college and Hospital,#41/E,Lalithadripura road,Mysuru-570028 Room no.10 Department of PG and Ph.D studies in Shalya Tantra.JSS Ayurveda Medical college and Hospital,#41/E,Lalithadripura road,Mysuru-570028
Mysore
KARNATAKA 		 9900802062
08212548360
prasannhanji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L975||Non-pressure chronic ulcer of other part of foot. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Sodhana-karma, षोधन-कर्म (Procedure Reference: sushrutha chikitsa sthana granthiapachiarbudagalaganda chikitsa adhyaya, Procedure details: PRE - OPERATIVE PROCEDURE. •Informed consent will be taken. •Subjects will be made to lie comfortably. •Inj.TT 0.5 ml IM stat will be given. OPERATIVE PROCEDURE: •Maggots will be washed with sterile water. •10-12 Sterile Maggots per each square cm will be applied on the site of wound covered with air permeable dressing. •Maggots are removed after 48 hours. POST - OPERATIVE PROCEDURE: •Proper bandaging will be done •Maggots used for debridement will be put in sodium hypochlorite solution, sealed with biodegradable garbage bag & later will be incinerated. )
2Comparator Arm (Non Ayurveda)-Surgical DebridementPRE - OPERATIVE PROCEDURE •Informed consent will be taken. •Lignocaine 2% subcutaneous 0.5 ml test dose will be given. •Inj.TT 0.5 ml IM stat will be given. •Subjects will be made to lie comfortably. •Painting and draping will be done. OPERATIVE PROCEDURE Under all aseptic precautions, Local anesthesia will be infiltrated around the wound. Slough will be removed using Allis forceps, Scissors, Artery forceps, Surgical blade, till appearance of healthy tissue, haemostasis will be attained POST - OPERATIVE PROCEDURE •Wound will be cleansed with normal saline, and proper bandaging will be done.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects of Grade I and Grade II Diabetic Foot Ulcer according to MEGGITT’S Classification of Diabetic Foot Ulcer.Irrespective of Gender,religion and occupation.
2.Diagnosed cases of Diabetic Foot Ulcers with 5cm× 4cm size (≤20cm2 area) and depth ≤ 1cm.

• Subjects with controlled Diabetes mellitus with HbA1c ≤ 6.5
 
 
ExclusionCriteria 
Details  • Subjects diagnosed as Diabetic Foot Ulcer with pre-gangrenous features and Gangrenous ulcers, Osteomyelitis, Abscess.
• Subjects diagnosed as Diabetic Foot Ulcer Suffering from systemic disorders like hypertension, HIV, HCV, HBsAg, STD, Tuberculosis, DVT.
• Subjects diagnosed as Diabetic Foot Ulcer Pregnant and lactating subjects.
• Subjects diagnosed as Diabetic Foot Ulcer Autoimmune disorders, genetic disorders.
• Subjects diagnosed as Diabetic Foot Ulcer with absence of Dorsalis pedis, Anterior and Posterior tibial pulse.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Attaining healthy granulation tissue and conversion of non healing ulcer to healing ulcer  1st 3rd 5th 7th 9th day  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the area of wound discharge & odour  1st 3rd 5th 7th 9th days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 1 
Date of First Enrollment (India)   17/12/2024 
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="3"
Days="3" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sushrutha Samhita being a pioneer classical reference in Ayurveda where Acharya Sushrutha described Maggots in debridement in the concept of Kaphaja arbuda management and certain drugs and materials as culture media to be utilized in cultivation of maggots  

  Un-affordability fear of losing limb profuse blood loss lack of awareness and false ideology regarding anaesthesia to the people are becoming the gateway towards nonsurgical care and treatment of Diabetic Foot Ulcer

  Hence  it is an attempt on the subjects who are diagnosed with Diabetic Foot Ulcer under the title of Kaphaja Dushtavrana based on its Lakshanas are taken for study and comparing Maggot debridement and Surgical debridement to evaluate the effect and bring rays on nonsurgical Maggot debridement

SAMPLE SIZE:

40 subjects suffering from Diabetic Foot Ulcer

·       Group A :20 Subjects will be treated with Maggot debridement.

·       Group B :20 Subjects will be treated with Surgical debridement.

PRE - OPERATIVE PROCEDURE

GROUP A:

·       Informed consent will be taken.

·       Subjects will be made to lie comfortably.

·       Inj.TT 0.5 ml IM stat will be given.

GROUP B:

·       Informed consent will be taken.

·       Lignocaine 2% subcutaneous 0.5 ml test dose will be given.

·       Inj.TT 0.5 ml IM stat will be given.

·       Subjects will be made to lie comfortably.

·       Painting and draping will be done.

OPERATIVE PROCEDURE:

GROUP A:

·   Maggots will be washed with sterile water.

·   10-12 Sterile Maggots per each square cm will be applied on the site of wound14, covered with air permeable dressing.

·   Maggots are removed after 48 hours.

 

 

GROUP B:

·   Under all aseptic precautions, Local anesthesia will be infiltrated around the wound. Slough will be removed using Allis forceps, Scissors, Artery forceps, Surgical blade, till appearance of healthy tissue, haemostasis will be attained.

POST - OPERATIVE PROCEDURE:

GROUP A:

·       Proper bandaging will be done

·       Maggots used for debridement will be put in sodium hypochlorite solution, sealed with biodegradable garbage bag and later will be incinerated.

GROUP B:

·       Wound will be cleansed with normal saline, and proper bandaging will be done.


 
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