Diabetic Foot UlcerInVeCoG:DFUNCT03740581
Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing
A study testing Insulin in people with Diabetic Foot Ulcer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients of DM according to ADA guidelines
- HbA1c >8% and/or FBG >130 on 3 consecutive occasions
- DFU: Wagner grade 2 \& 3 or UTS 2-3B
- Duration of ulcer <12 weeks
- Wound size: >1cm2
- Willingness to sign consent form \& participate in the study
- Capacity to attend visits at hospital for review
Who cannot join
- Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
- Dialysis requiring CKD \& eGFR <30 ml/min
- Active Charcot foot
- PEDIS 4: life threatening DFU
- Pregnancy
- ABI <= 0.7
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Medical Institute of Medical Education and Research
Chandigarh, 160012
Aditya Dutta, MD, +919818892996, addiedutta05@gmail.com
Ashu Rastogi, MD, DM, +919781001046, ashuendo@gmail.com
About this study
Official title: The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Insulin
- Keywords
- Diabetic foot ulcer, Intensive glycemic control
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)
| Study group | Role | What they receive |
|---|---|---|
| Intensive | Active comparator | New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day Receives: Drug: Insulin |
| Conventional | No intervention | Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
Ulcer area to be measured by Wound Measurement Camera model WZ2.0 (bought from (Wound zoom incorporate, 2916, Borham Ave, Stevens Point, W1, USA 54481) at baseline, 4 and 12 weeks.
Measured: 12 weeks
Secondary outcomes (4)
Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.
This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.
Measured: 4 and 12 weeks
HbA1c at 4 & 12 weeks in both intensive and conventional groups.
This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.
Measured: 4 and 12 weeks
Change in ulcer severity- Wagner and UTWSC classification.
Downgrade of ulcer severity based on two well established diabetic foot ulcer classification systems and there correlation with wound closure and glycemic control will be seen.
Measured: 4 and 12 weeks
Incidence of any amputation.
This outcome to be correlated with the glycemic control in both the groups.
Measured: 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Nov 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashu Rastogi, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740581
- Sponsor's protocol ID
- PGIMER ENDO
- Acronym
- InVeCoG:DFU
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03740581
- Acronym / sponsor ID
- InVeCoG:DFU / PGIMER ENDO
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Intensive glycemic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive | Active comparator | Drug: InsulinNew anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day |
| Conventional | No intervention | –Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years
- Patients of DM according to ADA guidelines
- HbA1c >8% and/or FBG >130 on 3 consecutive occasions
- DFU: Wagner grade 2 \& 3 or UTS 2-3B
- Duration of ulcer <12 weeks
Key exclusion criteria (7 listed)
- Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
- Dialysis requiring CKD \& eGFR <30 ml/min
- Active Charcot foot
- PEDIS 4: life threatening DFU
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinBasal Bolus regimen (Participant to receive, Insulin >= 3 times per day) | Drug | Intensive |
Primary outcome
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
Time frame: 12 weeks
Ulcer area to be measured by Wound Measurement Camera model WZ2.0 (bought from (Wound zoom incorporate, 2916, Borham Ave, Stevens Point, W1, USA 54481) at baseline, 4 and 12 weeks.
4 secondary outcomes
Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.
Time frame: 4 and 12 weeks
HbA1c at 4 & 12 weeks in both intensive and conventional groups.
Time frame: 4 and 12 weeks
Change in ulcer severity- Wagner and UTWSC classification.
Time frame: 4 and 12 weeks
Incidence of any amputation.
Time frame: 4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Diabetic Foot Ulcer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aditya Dutta, MD (+919818892996, addiedutta05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.