Diabetic Foot UlcersNCT01105884
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
A study testing Normal Saline, Biatin Ag (Foam) and Hydrocolloid in people with Diabetic Foot Ulcers, run by M.V. Hospital for Diabetes at 1 site in India.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Normal Saline, Biatin Ag (Foam) and Hydrocolloid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Jul 2012
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with foot ulcers
- Patients with or without PVD
- Size of the ulcer: 2-50 cm2
- Age 30-75 years (both gender)
Who cannot join
- Patient having severe infection
- Size of the foot ulcer > 50cm2
- Patients not willing to give written informed consent
- Patient with psychological disorder
- Patients with severe renal impairment or visual deformity
- Patients above the age of 75 years
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written informed consent prior to getting enrolled in the study. All the patients will be randomly assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam), Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete healing of the wound takes place. All procedures of dressing will be done by an authorized and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days required for the wound to completely heal will be recorded for all the patients.
This study will provide the efficacy of all the dressings used for treating diabetic foot ulcers and also the cost of each dressing. This will help the surgeons for managing the diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden of patients both physically and financially.
Read the detailed description
This prospective study aims at determining the efficacy and safety of different dressings available for treating diabetic foot ulcers. Study has been approved by the Institutional Ethics Committee before starting. Informed consent will be obtained from all the study subjects. A total of 50 subjects will be recruited. Study subjects will be divided in five groups of 10 subjects in each group.All the subjects will be randomly assigned to one of the study groups namely; Group 1 will the subjects randomized on Normal Saline (Control) and group 2 will be the subjects randomized on Biatin Ag (Foam) dressing; Group 3 will be Hydrocolloid, group 4 will be Hydrogel and Group 5 will be Ceredak. Lab investigations involving glycemic status (HbA1c), lipid profile, renal function test, liver function test will be done using standard enzymatic procedures. Wound size, colony count and microflora of the wound will be captured for all the study subjects. Photographs of the wound will be taken at every follow up visit until the wound is healed. Serum and tissue sample will be collected for the estimation of pronounced markers like MMP 2 and MMP 9. MMP 2 will be estimated using ELISA procedure (using standard enzymatic assay kit) and MMP 9 will be estimated using western blot technique. Histopathology of collagen will be seen using Van Gieson's stain. Immunohistochemistry will be done for determining collagen IV (marker for basement membrane thickening) to prove the evident wound healing at a defined point of time. H\&E sections will be taken for determining the inflammation histochemically. All the study subjects will be followed till the wound healing process is complete. Tissue and serum samples will be collected for the above mentioned parameters on pre application day, after 1st and 4th week of the dressing application. A total of 3 visits will be performed for all the study subjects.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Normal Saline, Biatin Ag (Foam), Hydrocolloid, Hydrogel, Ceredak
- Keywords
- Wound healing, type 2 diabetes, diabetic foot ulcers, different dressings
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineProcedure or surgery
All the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer
Biatin Ag (Foam)Procedure or surgery
Also called Coloplast
All the subjects will be treated with Biatin Ag (Foam)
HydrocolloidProcedure or surgery
Also called Coloplast
All the subjects in this group will be treated with Hydrocolloid
HydrogelProcedure or surgery
Also called Coloplast - Purilon Gel
All the subjects in this group will be treated with Hydrogel
CeredakProcedure or surgery
All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Procedure: Normal Saline |
| Group 2 | Active comparator | Not described Receives: Procedure: Biatin Ag (Foam) |
| Group 3 | Active comparator | Not described Receives: Procedure: Hydrocolloid |
| Group 4 | Active comparator | Not described Receives: Procedure: Hydrogel |
| Group 5 | Active comparator | Not described Receives: Procedure: Ceredak |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete healing of the wound
Measured: 1 months from the date of application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: Due to administrative reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.V. Hospital for Diabetes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijay Viswanathan, M.V. Hospital for Diabetes
- Investigators
- Vijay Viswanathan, Dr, Principal investigator, DRCRajesh Kesavan, Dr., Study director, DRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105884
- Sponsor's protocol ID
- CDS01
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2010
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01105884
- Acronym / sponsor ID
- CDS01
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Wound healing, type 2 diabetes, diabetic foot ulcers, different dressings
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to administrative reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.V. Hospital for DiabetesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 19 Apr 2010 (estimated)
- 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.
The purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written informed consent prior to getting enrolled in the study. All the patients will be randomly assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam), Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete healing of the wound takes place. All procedures of dressing will be done by an authorized and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days required for the wound to completely heal will be recorded for all the patients.
This study will provide the efficacy of all the dressings used for treating diabetic foot ulcers and also the cost of each dressing. This will help the surgeons for managing the diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden of patients both physically and financially.
Detailed description
This prospective study aims at determining the efficacy and safety of different dressings available for treating diabetic foot ulcers. Study has been approved by the Institutional Ethics Committee before starting. Informed consent will be obtained from all the study subjects. A total of 50 subjects will be recruited. Study subjects will be divided in five groups of 10 subjects in each group.All the subjects will be randomly assigned to one of the study groups namely; Group 1 will the subjects randomized on Normal Saline (Control) and group 2 will be the subjects randomized on Biatin Ag (Foam) dressing; Group 3 will be Hydrocolloid, group 4 will be Hydrogel and Group 5 will be Ceredak. Lab investigations involving glycemic status (HbA1c), lipid profile, renal function test, liver function test will be done using standard enzymatic procedures. Wound size, colony count and microflora of the wound will be captured for all the study subjects. Photographs of the wound will be taken at every follow up visit until the wound is healed. Serum and tissue sample will be collected for the estimation of pronounced markers like MMP 2 and MMP 9. MMP 2 will be estimated using ELISA procedure (using standard enzymatic assay kit) and MMP 9 will be estimated using western blot technique. Histopathology of collagen will be seen using Van Gieson's stain. Immunohistochemistry will be done for determining collagen IV (marker for basement membrane thickening) to prove the evident wound healing at a defined point of time. H\&E sections will be taken for determining the inflammation histochemically. All the study subjects will be followed till the wound healing process is complete. Tissue and serum samples will be collected for the above mentioned parameters on pre application day, after 1st and 4th week of the dressing application. A total of 3 visits will be performed for all the study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Normal Saline |
| Group 2 | Active comparator | Procedure: Biatin Ag (Foam) |
| Group 3 | Active comparator | Procedure: Hydrocolloid |
| Group 4 | Active comparator | Procedure: Hydrogel |
| Group 5 | Active comparator | Procedure: Ceredak |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with foot ulcers
- Patients with or without PVD
- Size of the ulcer: 2-50 cm2
- Age 30-75 years (both gender)
Key exclusion criteria (6 listed)
- Patient having severe infection
- Size of the foot ulcer > 50cm2
- Patients not willing to give written informed consent
- Patient with psychological disorder
- Patients with severe renal impairment or visual deformity
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 |
|---|---|---|
| Normal SalineAll the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer | Procedure or surgery | Group 1 |
| Biatin Ag (Foam)Also: ColoplastAll the subjects will be treated with Biatin Ag (Foam) | Procedure or surgery | Group 2 |
| HydrocolloidAlso: ColoplastAll the subjects in this group will be treated with Hydrocolloid | Procedure or surgery | Group 3 |
| HydrogelAlso: Coloplast - Purilon GelAll the subjects in this group will be treated with Hydrogel | Procedure or surgery | Group 4 |
| CeredakAll the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing | Procedure or surgery | Group 5 |
Primary outcome
complete healing of the wound
Time frame: 1 months from the date of application
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
Vijay Viswanathan, Dr principal investigator
DRC
Rajesh Kesavan, Dr. study director
DRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline, Biatin Ag (Foam) and Hydrocolloid in people with Diabetic Foot Ulcers, run by M.V. Hospital for Diabetes 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 4 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete healing of the wound (time frame: 1 months from the date of application). 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 4 Mar 2022.