| CTRI Number |
CTRI/2022/04/041672 [Registered on: 06/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to Evaluate the Efficacy and Safety of Wound Healing Topical Spray in Patients with
Diabetic Foot Ulcer.
|
|
Scientific Title of Study
|
A Randomized, Parallel, Multi-center, Double Blind, Double Arm, Comparative, Pilot Study to Evaluate the Efficacy and Safety of Wound Healing Topical Spray in Patients with
Diabetic Foot Ulcer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-055 Version 1.0 Dated 07 March 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GM Prasad |
| Designation |
Principal Investigator |
| Affiliation |
Pranav Diabetes Center |
| Address |
57/1 Nanda Complex Ramamurthy Nagar Main Road Banaswadi, Bangalore 560 043
Bangalore
KARNATAKA
560 043
India |
| Phone |
|
| Fax |
|
| Email |
drgmprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
2/5, Dahila Building, 3rd Floor
80 Feet Road, RMV 2nd Stage, Dollars Colony
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
2/5, Dahila Building, 3rd Floor
80 Feet Road, RMV 2nd Stage, Dollars Colony
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Pranav Diabetes Center 57/1 Nanda Complex Ramamurthy Nagar Main Road Banaswadi, Bangalore 560 043 |
|
|
Primary Sponsor
|
| Name |
Inzpera Healthsciences Limited |
| Address |
215-217, Avior Corporate Park Nirmal Galaxy, LBS Marg Mulund west, Mumbai - 400080 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GM Prasad |
Pranav Diabetes Centre |
Pranav Diabetes Center
57/1 Nanda Complex Ramamurthy Nagar Main Road Banaswadi, Bangalore 560 043
Bangalore
KARNATAKA |
9341231511
drgmprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal topical spray |
Herbal topical spray is a unique alkaline formulation. It is a combination of extracts of
herbs and natural amino sugars and natural adjuvants.
The unique Herbal Topical spray consists of mainly Aloe vera, Curcuma longa and Decalepis hamiltonii.Duration once a day for 10 weeks |
| Comparator Agent |
Standard of Care (SOC) treatment |
Standard of Care (SOC) treatment, in patients with DFU
Patient.Duration 10 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/female of ≥18 and ≤75 years of age.
2.Patient who can and willing to provide written Informed Consent.
3. Patient with a history of type 2 diabetes mellitus 4.
4.Patient having Random Blood Sugar [RBG] Ë‚ 250 mg/dL, on standard antidiabetic treatment.
5. Patient having glycosylated hemoglobin (HbA1c) of less than 12% (based on the existing reports).
6.Patient with at least ONE but not more than THREE DFU with wound surface area measured between 1 cm2 and 12 cm2 and depth post-debridement between 1cm2 -2cm2 , on the day of randomization (wound surface area measured by greatest length, greatest width).
7.Patient with ulcer located at or below malleolar region of foot and Superficial ulcer, Ulcer without infection, mild and moderate infection. Stage I-A, II-A or I-B on University of Texas wound classification system.
|
|
| ExclusionCriteria |
| Details |
1.Patient ˂ 18 or ˃ 75 years of age.
2. Pregnant and/or nursing woman.
3. Patient with more than 3 ulcers.
4. Patient with ulcers measuring wound surface area more than 12 cm2 and depth more than 2cm2.
5. Patient having severe or poorly controlled Type II diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
6. Patient having HbA1c of more than 12%.
7. Patient with severe ischemia with Ankle-Brachial Index (ABI) ≤ 0.7.
8. Patient having progressive weight loss.
9. Patient having poor nutritional status (S. albumin less than 2.5g /dL).
10. Patient with ulcer deep into bone and joint or Osteomyelitis or Severe ulcer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of subjects with complete healing of ulcer.
Complete healing’ will be defined as absence of visible wound by complete epithelialization.[Time Frame: 10 weeks ] |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time taken for achieving complete wound closure from the baseline [Time Frame: 10 weeks ]
2. Change in wound surface area from baseline [ Time Frame: 10 weeks ]
Mean percent change in wound area from baseline at each visit |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/04/2022 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes-related foot disease (DFD) is a serious public health issue that results in a
significant burden on healthcare resources and that severely impacts the quality of life of
individuals (Schaper NC. Et.al, 2020, Hinchliffe RJ et.al, 2020). Globally, about 83 to 148
million people with diabetes (19–34% of the total population with diabetes) are expected
to develop a foot ulcer in their lifetime (Armstrong DG et.al, 2017). Half of these foot
ulcers become infected (Lavery LA et.al, 2003), with over 15% requiring lower-extremity
amputation (Ramsey SD et.al., 1999). DFD is a major cause of hospitalisation worldwide,
which is mainly due to the lower limb amputation resulting from the disease (Armstrong
DG et.al, 2017, Kerr M. et.al., 2019)
The conventional treatment for DFU consist of weekly ulcer cleansing with saline,
debridement using a surgical blade, maintenance of a moist environment, and covering
with sterile gauzes. In addition, patients are instructed to perform daily cleansing with
saline-moistened gauzes and offloading the affected extremity. While most of these ulcers
can heal successfully, some remain nonhealing, leading to serious and debilitating
complications necessitating amputation of affected limb. |