| CTRI Number |
CTRI/2018/04/013411 [Registered on: 23/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of platelet concentrate dressing for the healing of diabetic foot ulcers |
|
Scientific Title of Study
|
An interventional study:Efficacy and safety of homologous platelet concentrate for the treatment of diabetic foot ulcers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SRINIVAS GEDALA |
| Designation |
PG RESIDENT |
| Affiliation |
Sri Manakula Vinayagar Medical college and Hospital |
| Address |
DEPARTMENT OF GENERAL SURGERY
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
KALITHEERTHALKUPPAM
MADAGADIPET, PUDUCHERRY
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7538881301 |
| Fax |
|
| Email |
srinivasgdl1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VINAYAGAMOORTHY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
KALITHEERTHALKUPPAM
MADAGADIPET, PUDUCHERRY
Pondicherry
PONDICHERRY
605107
India |
| Phone |
|
| Fax |
|
| Email |
drvinayagamoorthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinayagamoorthy V |
| Designation |
Assistant Professor |
| Affiliation |
Sri Manakula Vinayagar Medical college and Hospital |
| Address |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
KALITHEERTHALKUPPAM
MADAGADIPET, PUDUCHERRY
Pondicherry
PONDICHERRY
605107
India |
| Phone |
|
| Fax |
|
| Email |
drvinayagamoorthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sei Manakula Vinayagar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
Dr Srinivas Gedala
Postgraduate
Department of General Surgery
Sri Manakula Vinayagar Medical College and Hospital
Puducherry |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Srinivas Gedala |
Pondicherry |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL
KALITHEERTHALKUPPAM
MADAGADIPET, PUDUCHERRY
Pondicherry
PONDICHERRY |
7538881301
srinivasgdl1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with diabetic foot ulcers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
Routine dressing for diabetic foot |
| Intervention |
Intervention arm |
They receive platelet dressing for the diabetic foot |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.persons with type1 or type2 diabetes with denovo lower extremity diabetic ulcers
2.male and female,between ages 18-95
3.ulcer of atleast 4weeks duration with post debridement free of sinus tracts and tunneling and atleast 4cms from any additional wound
4.HbA1C <12
5.Wound measurement between 0.5 - 20 sqcm
6.full thickness without exposure of bone, muscle, ligament, tendon
7.the limb had to have adequate perfusion via ABI between 0.8 -1.5
8.no H/O infectious disorders in last 6 months
9.informed consent form signed |
|
| ExclusionCriteria |
| Details |
1. Non pregnant and non lactating women
2. Not on suppressants and ART
3. Ulcers of venous and arterial insufficiency
4. Bleeding and Clotting disorders
5. Patients on chemo and radiotherapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to healthy granulation tissue formation
2. Number of debridement and dressings
3. reduction in the ulcer size
4. SSG graft uptake
5. Adverse reactions |
Fifth day and ninth day after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SSG graft uptake for the intervention arm |
5th day, 9th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetic ulcer is a major public heath concern. About 15% of the diabetes patients develop chronic ulcer and 25% among them undergo foot amputation due to complications of various reasons. Deficiency of various growth factors related to neo-vascularisation is one among them. Platelets concentrate are rich in many of these growth factors along with anti microbial properties. So we planned the current study to assess the efficacy in healing of the diabetic ulcer among people treated with homologous platelet concentrate in comparison with people treated with standard dressing. We also want to look into the safety of single donor homologous platelet concentrate for the treatment of diabetic ulcer and the rate of graft uptake following split skin grafting. |