Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers: a Randomized Controlled Trial
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU), Offloading
Sponsor: ILS Hospital, Salt Lake

1 
 
 
 
 
Official Title: 
 
Posterior slab vs total contact cast in diabetic foot ulcers: a 
randomised controlled trial 
 
NCT number:  Not received yet 
 
Document date: 31/07/2025 
 

1 
 
PROTOCOL 
ILSS/EC/0012-DFU/2022 
 
 
POSTERIOR SLAB VS TOTAL CONTACT CAST IN DIABETIC FOOT 
ULCERS: A RANDOMISED CONTROLLED TRIAL 
ILS Hospital, DD-6, Sector-1, Salt Lake, Kolkata-700064, West Bengal 
 
 
Table of Contents 
 
 
1. Affiliation 
Page 2 
 
2. Introduction 
Page 3 
 
3. Aim and Objectives 
Page 3 
 
4. Inclusion & Exclusion criteria 
Page 3 
 
5. Materials and Methods 
Page 4 
 
6. Outline of time plans 
Page 4 
 
7. Statistical analysis 
Page 4 
 
8. Ethics 
Page 4 
 
9. Sources of funding 
Page 4 
 
10. Primary References 
Page 5 
 
11. Copy of Consent Forms 
Page 6 
 
12. Copy of Foot History File 
Page 9 
 
13. CV, MRC & GCP 
Page 17

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1.  AFFILIATIONS 
Research Institute 
ILS Hospital, Salt Lake. 
Address: DD-6, Sector 1, Salt Lake City, Kolkata-700064 
 
 
Principal Investigator-cum-Guide :  Dr. Ghanshyam Goyal 
Address: ILS Hospital, Salt Lake, 
DD-6, Sector 1, Salt Lake City, Kolkata-700064  
Phone Number: +91-9830400450 
Email: drgsgoyal@hotmail.com 
 
 
Co-Guide 
: 
Dr. Rekha Srivastav 
Address: ILS Hospital, Salt Lake, 
DD-6, Sector 1, Salt Lake City, Kolkata-700064 
Phone Number: +91-9831058704 
Email: ins.rekha@gmail.com 
 
 

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2. INTRODUCTION 
 
There are three basic principles in the management of diabetic foot ulcer (DFU) – adequate 
debridement and infection control, adequate vascularity, and adequate offloading. Off-loading of 
the ulcer area is extremely important for the healing of neuropathic plantar ulcers. Total Contact 
Cast (TCC) remains the gold standard treatment of Diabetic Foot Ulcer (DFU). However, there are 
many practical problems associated with TCC, including local skin irritation, worsening of 
deformed toe nails, fungal infections, claustrophobia, joint rigidity, atrophy of the smaller foot 
muscles, postural instability and painful leg and calf muscles. So, TCCs are underutilized in clinical 
practice as they are technically difficult and time consuming to apply, relatively expensive and have 
low patient tolerance. Their use is also contraindicated in patients with infected or ischaemic ulcers. 
Posterior slab cast (PSC) is also a good offloading modality in neuropathic DFU.  It can be more 
convenient and economical as a single slab can be used till complete healing is achieved. Thus may 
provide a lesser invasive way of immobilization of the foot in DFU. 
 
3. AIM & OBJECTIVES 
 
Aim of this trial is to compare the efficacy of Posterior slab cast (PSC) with Total Contact cast 
(TCC) in terms of wound healing and foot related outcomes in patients having neuropathic planter 
diabetic foot ulcers in a tertiary care diabetic foot clinic. 
 
4. INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion criteria 
 
1. Type 2 Diabetes Mellitus 
2. Having solitary neuropathic plantar ulcer 
3. Ulcer belonging to Wagner’s grade 2 or 3 
 
Exclusion criteria 
1. Persons with bilateral DFUs 
2. Peripheral vascular disease (ABI < 0.9) 
3. Gout 
4. steroid intake in the last three months, 
5. Stage 4 & 5 chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 
ml/min/m2, 
6. Bilateral foot involvement, 
 
 
 
 
 
 
 
 
 
 
 
 

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5. MATERIAL & METHODS 
 
It is an open label randomized control trial. It will be done in ILS Hospital, Kolkata for a trial 
period of around 3 years.  
 
Diabetic patients attending the foot clinic with plantar ulcer irrespective of age, sex, glycemic 
control, duration of diabetes, duration of ulcer and presence of infection will be considered for the 
study. At first patients will be randomly allocated to any one of two off-loading procedures using 
the randomization table: TCC or PSC. Those who will refuse TCC, will be shifted to PSC group. 
All patients will be followed up at the foot clinic once in two weeks’ basis for device inspection, 
wound care and wound debridement as and when indicated. After the completion of treatment, all 
the patients will be followed up to 15 months from the initiation of treatment to identify any 
recurrence of ulcer. 
Two outcome measures will be used. The primary outcome measure is healing of the ulcer after 8 
months. The secondary outcome measure is to document which of the device is associated with 
comparatively better healing at 6 months.  
 
6. OUTLINE OF TIME PLANS: 
Proposed date of starting research activity: January 2023 
Expected duration of research activity: 1.5 years 
Undertaking to provide interim report of the work halfway through it: Yes 
Undertaking to provide full report of the work on completion: Yes 
 
7. STATISTICAL ANALYSIS: 
Comparison will be done between the two groups. Continuous variables will be compared by t-
tests and categorical variables by chi-square test. Baseline comparison will be made using chi-
square tests and two-sample t-tests. Continuous variables will be expressed as mean (standard 
deviation). The differences in pertinent characteristics will be established with the use of t-test for 
independent samples. A two-sided p value of 0.05 was considered statistically significant. 
 
8. ETHICS 
 
01) Subject information brochure: Yes 
02) Informed consent form: Yes 
03) Statement of conflict of interest, if any: None 
 
Publication-plans for the outcome (positive or negative) while maintaining the privacy and 
confidentiality of the study participants: 
 
The privacy and confidentiality of the study participants will be maintained in all 
publications/reports originating from this study. 
 
9. SOURCE(S) OF FUNDING: 
 
Not Applicable 
 

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10. 
 PRIMARY REFERENCES: 
 
1) A mouldable fibreglass backslab device as a novel approach to offload chronic plantar foot 
ulcers: A retrospective observational audit; First published: 21 August, 
2024,https://doi.org/10.1002/jfa2.70001 
2) Li B, Lin A, Huang J, Xie J, Liu Q, Yang C, Zhang Z. Total contact casts versus removable 
offloading interventions for the treatment of diabetic foot ulcers: a systematic review and meta-
analysis. Front Endocrinol (Lausanne). 2023 Sep 26;14:1234761. doi: 
10.3389/fendo.2023.1234761. PMID: 37822605; PMCID: PMC10562689 
3) A Comparative Study Between Total Contact Cast and Pressure-Relieving Ankle Foot Orthosis 
in Diabetic Neuropathic Foot Ulcers; Partha Pratim Chakraborty et al; Journal of Diabetes 
Science and Technology 2015, Vol. 9(2) 302 –308 © 2014 Diabetes Technology Society 
Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 
10.1177/1932296814560788 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11. 
 COPY OF THE CONSENT FORMS: 
 
POSTERIOR SLAB VS TOTAL CONTACT CAST IN DIABETIC FOOT 
ULCERS: A RANDOMISED CONTROLLED TRIAL 
 
Study to be conducted by: Dept of Diabetology & Diabetic Foot Clinic, ILS Hospitals, Saltlake 
You are being invited to participate in a clinical research trial. The following information is for 
you to understand why the research is being done and what it will involve. Please take time to 
read it carefully and discuss with friends, relatives and your family doctor if you wish. Please 
feel free to ask us if there is anything that is not clear or if you would like more information. 
Take time to decide whether or not you wish to take part. Please sign the Informed Consent Form 
only if you are fully satisfied with the information given to you and you understand the 
procedures involved in the study. 
What is the purpose of the trial? 
 
Aim of this trial is to compare the efficacy of Posterior slab cast (PSC) with Total Contact cast 
(TCC) in terms of wound healing and foot related outcomes in patients having neuropathic 
planter diabetic foot ulcers in a tertiary care diabetic foot clinic. 
 
Why have I been chosen? 
 
Diabetic patients having solitary neuropathic plantar ulcer have been chosen for the study. You  
have been selected because you have an foot ulcer and also satisfy the other selection criteria for  
the study. 
Do I necessarily have to take part? 
 
No, it is up to you to decide whether or not to take part. If you decide to take part, you will be  
asked to sign a consent form. Even after you have decided to take part, you are still free to  
withdraw anytime you choose without giving us a reason. A decision to withdraw, or a decision  
not to take part, will not affect the quality of care you receive. 
What happens during the study? 
 
If you agree to participate, no extra intervention will be done and neither any special drugs will  
be used. We will use the post-trial data generated for a clinical research purpose. 
Are there any other possible disadvantages of taking part? 
No disadvantages since the data generated post-trial will be used for research purpose. 

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Will my taking part in this study be kept confidential? 
 
Yes. All data obtained from the study will be kept confidential. The data would be archived for  
an appropriate period. This data will be used only by authorized persons for scientific purposes. 
 
What will happen to the results of the study? 
A study report will be finalized soon after the trial closes. This will be submitted to the ethics  
committee of the institute carrying out the study, and also to government authorities if needed.  
The results may be published in a scientific journal or discussed at a scientific forum. You will  
however, not be identified in any report / publication. 
 
Contact for further information: 
The doctors conducting this study can discuss it in more detail with you and reply to any query, 
when it arises. The contact persons are: 
 
Dr. Ghanshyam Goyal 
Principal Investigator 
ILS Hospital, Saltlake 
DD-6, Sector-1, Salt Lake City, 
Kolkata - 700064 
Ph No:+91-983040450 
Email: drgsgoyal@hotmail.com 
 Dr. Rekha Srivastav 
Co-Guide 
ILS Hospital, Saltlake 
DD-6, Sector-1, Salt Lake City,  
Kolkata - 700064 
Ph No: +91-9831058704 
Email: ins.rekha@gmail.com 
Principal Investigator - cum - Guide 
Co-Guide 
 
 
 
 
 
 
 
 
 
 
Thank you for going through the Patient Information Sheet. 
Should you decide to participate in this clinical study, we thank you for that too. 

8 
 
INFORMED CONSENT FORM 
POSTERIOR SLAB VS TOTAL CONTACT CAST IN DIABETIC FOOT 
ULCERS: A RANDOMIED CONTROLLED TRIAL 
 
 
Patient’s: Name:  
Initials  
Age  
Sex  
 
 
1. I confirm that I have read and understood the information sheet for 
the above study and have had the opportunity to ask questions. 
[ 
] 
2. I understand that my participation in the study is voluntary and that I am 
free to withdraw at any time, without having to give a reason, and 
without my medical care or legal rights being affected. 
[ 
] 
3. I understand that my data would be kept confidential but individuals 
authorized by the Principal Investigator, the ethics committee of the institute 
where the study will be conducted and government drug regulatory authority 
will have access to my health records both in respect of the current study 
and further research that may be conducted in relation to it. Even if I withdraw, 
I agree to this access. However, I understand that my identity will not be 
revealed and confidentiality of information will be maintained. 
[ 
] 
4. I agree not to restrict the authorized use of any data or results that arise 
From this study. 
[ 
] 
5. I agree to voluntarily take part in the above study. 
[ 
] 
Signature / Thumb impression of the subject:  
 
Date:  
Place:  
 
Study doctor’s name:  
 
Study doctor’s signature:  
Date:  
Place:  
 
Mandatory where subject has provided thumb impression: 
Signature of the witness: 
 
 
Date:  
Place: 
  
Name & Address of the witness: 
 
   
 
Relation to the subject, if any: 
 

9 
 
 
 
12. 
COPY OF HISTORY FILE  
 
                     POSTERIOR SLAB VS TOTAL CONTACT CAST IN DIABETIC FOOT 
ULCERS: A RANDOMIED CONTROLLED TRIAL 
 
CASE REPORT FORMS 
TO BE FILLED AT THE TIME OF FIRST OP VISIT 
 
 

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NAME: ……………………………………………………………..………… AGE: ……………..….....  SEX: ………………..… 
 
 
ADDRESS: …………………………………………………………………………………………………………………..………… 
 
 
MOB.NO: ………………………………………………………REFFERING DR.: ………………………………………………… 
 
MEDICAL 
HISTORY 
 
DIABETIC FOOT HISTORY 
 
 
 
RT 
LT 
Duration of 
Diabetes 
 
Duration of Ulcer 
 
 
Duration of  
Hypertention 
 
Past H/O Ulcer 
 
 
Hight 
 
H/O Amputation 
 
 
Weight 
 
Joint pain 
 
 
BMI 
 
Stiffness 
 
 
Dyslipidemia 
 
Dry skin 
 
 
SMOKER 
 
Numbness 
 
 
CVD  
 
Tingling/Pricking 
 
 
CKD 
 
Paresthesia 
 
 
Blood Sugar 
 
Claudication 
 
 
HbA1C 
 
Cramping 
 
 
 
 
Oedema 
 
 
 
EXAMINATION OF FOOT 
INSPECTION 
DRY SKIN 
   YES 
    NO 
 
ABNORMAL 
SHAPE 
    YES 
    NO 
 
FISSURE 
   YES 
    NO 
NAIL LESION 
    YES 
    NO 
DEFORMIT
Y 
    YES 
    NO 
 
LOSS OF HAIR 
    YES 
    NO 
 
CALLUS 
    YES 
    NO 
 
 
 
 
 
 
 
 
 
 
 
 
 
PALPATION 
HOT 
COLD 
NORMA
L 
RIGHT 
 
 
 
LEFT 
 
 
 
FOOT PULSES 
RT 
LT 
DORSALIS  
PEDIS 
         
 
POTERIOR  
TIBIALIS 
         
 
ASSESSMENT OF 
NEUROPATHY 
RIGHT 
RIGHT 
LEFT 
LEFT 
MONOFILAMENT 
 
 
 
 
VPT 
 
 
 
 
HCP 
 
 
 
 
 
 
 
 

 
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VASCULAR 
ASSESSMENT 
RIGHT 
LEFT 
DORSALIS PEDIS 
 
 
POSTERIOR TIBIALIS 
 
 
BRACHIALIS 
 
 
ABI 
 
 
RADIOLOGICAL INVESTIGATION (X RAY FOOT) 
 
RT:- 
LT:- 
DESCRIPTION OF ULCER 
Location :– 
Size:- 
Base:- 
Margins:- 
Depth:- 
CLINICAL DIAGNOSIS 
 
WEGNERS CLASSIFICATION 
 
YES 
NO 
 
Grade-0 
 
NEUROPATH
Y 
 
 
1-Superficial Ulcer 
 
CHARCOT 
FOOT 
 
 
2-Deep Ulcer 
 
PVD 
 
 
3-Osteomyelitis 
 
INFECTED 
 
 
4-Localized Gangrene 
 
OTHERS 
 
 
5-Extensive Gangrene 
 
TREATMENT 
YES 
NO 
Callus and Corn Removed 
 
 
Nail paring 
 
 
I+D done 
 
 
Pus for CS 
 
 
Probing 
 
 
Extensive debridement 
 
 
Surgical Referral 
 
 
Others 
 
 
OFFLOADING TECHNIQUE 
YES 
NO 
S K OFFLOADING 
 
 
OFFLOADING SHOE 
 
 
TOTAL  CONTACT  CAST 
 
 
INSTANT  TCC 
 
 
CUSTOM  FOOTWEAR 
 
 
OTHERS 
 
 
FOLLOW UP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
17 
 
             Specialised Medical Personnel Curriculum Vitae 
 
 
Full Name: 
 
DR. GHANASHYAM GOYAL 
Academic Title: 
SENIOR CONSULTANT - DIABETOLOGI ST 
Present Position: 
PRINCIPAL INVESTIGATOR 
Business Address: 
 I  L S Hospltal  DD·  6, SEC-1 ,SALTLAKE,KOL-
64 
Relevant Education: 
(Type of degree and year when 
awarded) 
MBBS-1984, MD-1988 
Relevant   Previous   Positions : 
(Name of institution and/or 
organisation and year) 
Director & Consultant Diabetologist &  Diabetic Foot 
Specialist, S.K. Diabetes  Research  and  Education 
Centre,Kolkata - February 2006 - till date 
Consultant,Dept. of Internal Medicine and Head, Dept. of 
Dlabetology, ILS Hospital,Kolkata - January 2002 - till 
date 
Consultant Physician & Diabetologist - Unit Head, 
MRS Hospitals - January 1996 - 2002 
Consultant Physician & Diabetologist - MRS 
Hospitals, Kolkata June 1991 - December 1995 
Chief Resident - Dept. of Internal Medicine - MRS 
Hospitals, Kolkata - October 1988 - May 1991 
Relevant Job Related Training: 
(Year of attendance,type of 
qualification 
e.g.specialist courses) 
Quintiles Online GCP - 2011 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Relevant Clinlcal Trial and Research Experience 
including GCP Training: 
PRINCIPAL INVESTIGATOR :  
A trial comparing the efficacy and safety of 
insulin degludec I liraglutide and insulin 
degludec in subject with type 2 diabetes. 
 
PRINCIPAL INVESTIGATOR : 
Efficacy and Safety of H0/03/03 10 ug in the 
treatment of Neuropathic Diabetic Foot 
Ulcers - A PHASE II TRIAL ( a double 
blind placebo controlled ,Multicentre study) 
 
PRINCIPAL INVESTIGATOR  : 
BIOCHAPERONE PDGF   -  BB   - A    
phase    I/II,    multicentre, 
randomized,controlled, open label trial 
comparing the 
efficacy and safety of two dose regimens of 
BioChaperone POGF - BB to becaplermin 
gel for the treatment of diabetic foot ulcer. 
 
DIABESITY: Role of Insulin Detemir,an open label, 
observational, multicentric, randomized study in April 
2008. 
Other Activities Pertinent to Professional 
Qualifications 
INSUTREAT: A registry to study the effect 
of changes of existing Insulin treatment in 
Inadequately controlled Type 2 diabetes patients 
till February 2007. 
 
The IMPROVE: study  A multicentre,open 
label, non randomized, non interventional, 
observational, safety & effectiveness study in 
subjects using Biphasic Insulin Aspart 30 for 
t he treatment of DM in 2007. 
Certifications and Licensures: 
(Optional) 
Diabetology research course in 
genetics (Star Steno diabetes educatiori 
project} at Bangalore inAugJst, 2005. 
 
Advanced Diabetes & Endocrinology 
Preceptorship at John Hopkin's University, 
School of Medicine, Baltimore, USA in 
March  2008. 

 
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Faculty & Trainer  Staged Diabetes 
Management for Physicians, conducted by 
International Diabetes Centre. 
 
Started the first Diabetic Foot Clinic of 
Kolkata & Eastern India in 2003 
 
Regional Coordinator :"National 
Wound Care Project"(WOF DFSI) 
 
Regiona Faculty - Certificate Course in 
Evidence Based Diabetes Management 
conducted by Public Health Foundation of 
India ( PHFI) 
 
Conducting Workshops on Diabetic Foot 
all across the country to inc ease 
awareness amongst Paramedics, 
Physicians and D1abetologists 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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NAME: DR REKHA BASAK SRIVASTAVA 
 
E-MAIL  ID: ins.rekha2@gma il.com 
 
EDUCATIONAL QUALIFICATION:  
B Sc, BAMS 
Clinical podiatrists and Chief Clinical Research Co ordinator - ILS Hospital, Kolkata 
PROFESSIONAL TEAC HING EXPERIENCE TILL DATE: 
 
1. Best paper presentation award in DFSI KOLKATA'2008 
 
2. Master trainer ofIDF Certified course- project HOPE (Indian diabetic educator project) 
 
3. Chief of clinical podiatry program me, conducted workshops at different medical 
colleges under DFSI wound care project 
4. Conducted workshops at different states under Diabetic Foot Education Programme 
(DFEP). 
 
5. Conducting patient education programme  for Diabetes and Diabetic foot every 
month at ILS HOSPITAL ,SALT LAKE. 
Working as Clinical Research Co ordinator : 
 
1. A Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and 
Control Group Clinical Trial to Assess the Effectiveness of Biochaperone PDGF-
BB in the Treatment of Chronic Diabetic Foot Ulcer 
2. A trial comparin g the efficacy and safety of insulin degludec I liraglutide and 
insulin degludec in subject with type 2 diabetes. 
3. Efficacy and Safety of H0/03/03 10 ug in the treatment of Neuropathic Diabetic 
Foot Ulcers - A PHASE II TRIAL ( a double blind placebo controlled 
,Multicentre study) 
4.  BIOCHAPERO NE PDGF - BB - A phase I/II, m u lticentre, randomized, 
controlled , open label 
trial compari ng the efficacy and safety of two dose regimens of BioChaperone 
PDGF - BB to becaplermin gel for the treatment of diabetic foot u lcer. 
5. "Evaluation of Safety and Efficacy of Hydroxychloroquine Sulfate as an Adjunct 
to Diet 
and exercise to Improve Glycemic Control in Type 2 Diabetes Patients 
Uncontrolled on Sulfonylurea + 
etformin Combination" with  tudy Code: 
Ipca/HCQS/PIV-14. 
6. Study GOAL: Study of clinical and non clinical predictive factors for achieving 
glycemic control in people with type 2 diabetes in real clinical practice. 
7. Effect and safety of semaglutide 2.4 mg once-weekly in subjects with 
                overweight or obesity and type 2 diabetes. 
 
 

 
21 
 
 
 
8.  ATOS I A Toujeo ® Observational Study 
A 12 month prospective observational study assessing the real world clinical 
effectiveness , safety and health economic benefits of Toujeo ® initiation after oral 
antidiabetic drug failure in insulin natve patients with type 2 diabetes mellitus 
9. Study Title:A Label extension, Randomized, Double Blind, Placebo Controlled, 
Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of 
Peri-ulcer Administration of stempeucel®  (Adult  Human  Bone  arrow  Derived,  
Cultured,  Pooled,  Allogeneic Mesenchymal  Stromal Cells) in Patients with 
Non-Healing Diabetic Foot Ulcer. 
10. The clinical trial "An observational, Cross sectional Study to assess the 
Prevalence of Heart Failure in Type 2 Diabetes Patients in India. Study Code: 
D1843R00300 " 
11. The clinical trial "A Label extension, Randomized, Double Blind, Placebo 
Controlled , Multicentre , Single Dose, Phase III Study Assessing the Efficacy 
and Safety of Peri- ulcer Administration of stempeucel® (Adult Human Bone 
Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in 
Patients with Non-Healin g Diabetic Foot Ulcer. 
12. The clinical trial "Ref: I8F- MC-GPHK: Efficacy and Safety of Tirzepatide Once 
Weekly in Participants without Type 2 Diabetes Who Have Obesity or are 
Overweight with Weight- Related Comorbidities : A Randomized, Double-Blind, 
Placebo- Controlled Trial(SURMOUNT - 1)" 
CAREER HIGHLIGHTS : Clinical Podiatrists since last 15 years. 
 
Trained the paramedics on field of podiatry. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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