Plain English Summary
Background and study aims
Nerve damage (diabetic neuropathy), is common in some Diabetic patients suffering from Diabetes for a long time. Nerve damage can lead to numbness, pain and weakness in the affected area of the body. Neuropathy in the soles of the feet is more common than anywhere else. The wounds developed in the soles of Diabetic patients are termed as Diabetic Foot Ulcers (DFUs). Diabetic Foot Ulcers can be treated through conventional methods but might keep recurring due to the loss of sensation in the soles. Diabetic Neuropathy is not easily treated in conventional therapies and needs holistic management of the metabolic disorder itself and possible regeneration of nerves in soles of patients suffering from Diabetic Neuropathy and Diabetic Foot Ulcers.
The objective of the study is to clinically establish the role of energy (Pranic) healing as complementary therapy in the management of Diabetic Foot Ulcers (DFUs) in Wagner classification Grade 1 - 3. Wagner scale classifies the wounds depending on their depth and severity. A lower grade implies a superficial wound and a higher grade implies a wound that had gone deep.
Who can participate?
Diabetic patients (men and women) in the age group of 25 - 75 years, visiting the super-speciality referral centre and presenting with Diabetic Foot Ulcers in Wagner scale 1-3 can enrol for the study. Pregnant women and smokers will be excluded.
What does the study involve?
The study involves Pranic healing treatment as complementary therapy in the management of Diabetic Foot Ulcers (DFUs) in Wagner classification Grade 1-3. Half of the participants recruited will be allocated to the trial group i.e Pranic Healing intervention along with standardised medical care for Diabetes and optimum wound care. The other half will be allocated to the control group; i.e. not receive Pranic healing as a complementary therapy, but only receive medical care for Diabetes and optimum wound care.
Pranic Healing protocols for Diabetes Type-2 and local wound healing and regeneration of nerves in the soles and Psychotherapy for stress will be undertaken for the participants in the trial group.
What are the possible benefits and risks of participating?
The possible benefits of enrolling in the study are accelerated wound healing in terms of size and area of the wound, wound bed appearance, sensory changes in the soles, better glycemic control and reduced stress.
There has been no side effect of energy (Pranic) healing to date.
Risks:
• Thromobosis/ other complications while drawing blood for tests
• Infection of wound, high blood sugar levels, cardiovascular complications
• Patients not following instructions and assuming that the intervention is supposed to replace the conventional treatment
Where is the study run from?
Karnataka Institute of Endocrinology & Research (India)
When is the study starting and how long is it expected to run for?
September 2019 to November 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Anuradha Nittur
anuradha2nittur@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Ms Anuradha Nittur
ORCID ID
http://orcid.org/0000-0003-1724-2762
Contact details
Mantri Woodlands
Arekere Layout
Bannerghatta Road
Bangalore
560076
India
+91 8888913348
anuradha2nittur@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A randomised, double-blind, comparative pilot study to assess the efficacy of short term pranic healing as a complementary therapy in diabetic foot ulcer management in men and women in the age group of 25-75
Acronym
COMPDIAM-DFU
Study hypothesis
Short term Pranic Healing intervention can play a significant role in providing complimentary therapy in managing Diabetic Foot Ulcers in patients suffering from diabetes
Ethics approval
Approved 14/09/2019, Institutional Ethical Committee, Karnataka Institute of Endocrinology & Research (KIER) (SJICR Campus , Bannerghatta Road, 9th Block, Jayanagar, Bengaluru-560069, India; +918026647222; ieckier2017@gmail.com ), ref: IEC-KIER 16/14.09.2019
Study design
Randomised, double-blind, comparative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See https://drive.google.com/drive/folders/120trMumZMmCHBYtcGAD1z9NPKjfQe5uJ?usp=sharing
Condition
Diabetic foot ulcers, stress, and nerve regeneration in soles in diabetic patients
Intervention
Pranic Healing protocols for Diabetes Type-2, local wound healing and regeneration of nerves in the soles and Psychotherapy for stress will be followed. Participants will be randomly selected, informed and assigned to the trial or control (no treatment) group as per a computerised random table.
The subjects in the trial group will be provided complimentary healing in the form of Pranic Healing - a no-touch, no-drug energy healing modality every day for 50 - 60 minutes along with standardised wound care and medication for diabetes and co-morbidities for five weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Size and severity of Diabetic Foot Ulcer measured using pictures of the wounds taken on recruitment and at the end of the trial and wound area compared either through the wound zoom camera or using Image J software which will be examined by the clinician and measurements and characteristics noted at recruitment and end of the trial
2. Improved sensation in soles measured through Monofilament and Vibratory Perception Threshold tests using last available reading before the start of the trial and measured at the end of the trial
3. Stress, general well being and appetite measured by means of a questionnaire administered at the end of the trial
Secondary outcome measures
Glycemic level measured through Hba1c or FBS tests using last available reading before the start of the trial and measured at the end of the trial
Overall trial start date
08/08/2019
Overall trial end date
16/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women in the age group of 25 - 75 years
2. Presence of diabetic foot ulcers in Wagner grade 1 - 3
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Pregnant women
2. Smokers
Recruitment start date
16/09/2019
Recruitment end date
12/10/2019
Locations
Countries of recruitment
India
Trial participating centre
Karnataka Institute of Endocrinology & Research
Sri Jayadeva Institute of Cardiovascular Sciences and Research Campus
Bannerghatta Road
9th Block
Jayanagar
Bangalore
560069
India
Sponsor information
Organisation
Center for Pranic Healing
Sponsor details
420 Valley Brooke Avenue
Lyndhurst
New Jersey
07071
United States of America
+1 512-953-7474
info@PranicHealingResearch.com
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to submit the report of the Pilot project for publication as soon as the registration is complete.The report is ready to be submitted in relevant peer reviewed journals.
This will hopefully be followed by a full fledged Clinical Trial.
The results of the pilot project will be shared in relevant medical Conferences and workshops.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
15/02/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN17141223_PROTOCOL.pdf uploaded 24/02/2020