FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/012220 [Registered on: 28/02/2018] Trial Registered Prospectively
Last Modified On: 28/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of blood component and dextrose injection in patients of chronic severe plantar fasciitis 
Scientific Title of Study   A randomized control trial to compare the effect of platelet rich plasma and dextrose prolotherapy in patients of chronic severe plantar fasciitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna B 
Designation  Junior Resident 
Affiliation  AIIMS 
Address  Department of PMR AIIMS Ansari Nager East New Delhi

South
DELHI
110029
India 
Phone  812981744  
Fax    
Email  beekrishna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gita Handa 
Designation  Professor 
Affiliation  AIIMS 
Address  Department of PMR AIIMS Ansari Nager East New Delhi

South
DELHI
110029
India 
Phone  09818694060  
Fax    
Email  gitahanda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Krishna B 
Designation  Junior Resident 
Affiliation  AIIMS 
Address  Department of PMR AIIMS Ansari Nager East New Delhi

South
DELHI
110029
India 
Phone  812981744  
Fax    
Email  beekrishna@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Krishna B 
Address  Department of PMR AIIMS, New Delhi 
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 
Krishna B  AIIMS  Room 17,Dept of PMR
South
DELHI 		 8122981744

beekrishna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee for post graduate research ,AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Plantar fasciitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  15% dextrose solution  1.5 mL of 25% dextrose is mixed with 1ml of 2% lignocaine taken in a 5mL syringe to make 2.5ml of 15% dextrose solution 
Comparator Agent  Platelet rich plasma  To prepare the PRP, 20 ml of peripheral blood will be extracted from each patient’s cubital fossa by venepuncture into a 20ml sterile single use plastic syringe with 2.5 ml of anticoagulant (CDPA). The extracted blood will then be centrifuged at 1000 rpm (190G) for 4 minutes at room temperature. once centrifuged, under sterile conditions, we will pipette out the plasma rich in platelets remaining above the red series and the “buffy coat” from the tubes into a sterile tube, and injected under aseptic precautions  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient diagnosed with unilateral or bilateral plantar fasciitis having no improvement with conservative management for ≥ 3 weeks.
2.Physical examination revealing maximum tenderness at the attachment of plantar fascia on the medial tubercle of the calcaneus.
3.Ultrasound examination showing plantar fascia thickness ≥4 mm or difference in plantar fascia thickness ≥1 mm in symptomatic heel in comparison to asymptomatic heel at inferior border of the calcaneus.
4.In bilateral cases, foot with more clinical severity is taken into the study
 
 
ExclusionCriteria 
Details  1.Received local steroid injection within 6 months
2. NSAID use 7 days prior to randomization
3. History of anaemia or bleeding disorders
4. Previous surgery for plantar fasciitis
5. Achilles tendon pathology
6.Diagnosed case of local malignancy
7.Diagnosed case of rheumatological diseases
8.Uncontrolled diabetes mellitus
9.Patients on anticoagulation therapy
10. Diagnosis of vascular insufficiency or neuropathy related heel pain (radiculopathy, tarsal tunnel syndrome) and other causes of heel pain
11. Any local trauma or infection.
12.Not willing to participate in study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in sonographic appearance of the plantar fascia, with respect to thickness and presence or absence of hypoechogenic foci  0 weeks , 4 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in functional outcome assessed by Foot Function Index  0 weeks, 4 weeks, 8 weeks 
Change in symptom severity assessed by Foot Function Index  0 weeks, 4 weeks, 8weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Plantar fasciitis is the most common cause of inferior heel pain affecting 10-15% of general population at least once in their lifetime. Studies have shown that roughly 10 percent of plantar fasciitis patients are nonresponders to conservative treatment.
Surgical correction of plantar fasciitis involves open/percutaneous or endoscopic plantar fascia release which is associated with increased stress on ligaments of forefoot and midfoot resulting in further complications. This creates a window for injection therapies in non-responders to conservative management. Commonly used local steroid injection has been associated with atrophy of plantar fascia, subcutaneous fat and even plantar fascia rupture. Moreover, steroids are generally indicated in acute, not chronic cases, which is the focus of this study.
On the other hand, prolotherapy with dextrose (DP) has been reported to decrease pain and improve function in a variety of tendinopathies, by upregulating multiple mitogenic factors. And, complete resolution of symptoms at one year was reported in 75% of subjects with plantar fasciitis treated with PRP by Barrett SL et al.
But, no trial has directly compared the effectiveness of dextrose prolotherapy with PRP in chronic plantar fasciitis in Indian population. Nor have any studies compared change in ultrasound parameters, as an outcome measure between PRP and DP in chronic plantar fasciitis.
 
Close