Diabetic FootNCT06450015
Comparison of Vacuum Assisted Closure and Saline Dressing in Patients With Diabetic Foot Ulcers
A study testing Vacuum Assisted Closure and Saline Dressing in people with Diabetic Foot, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial summary
Conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that VAC dressing gives better results as compared to conventional saline dressing in treating Diabetic Foot Ulcers. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Vacuum Assisted Closure and Saline Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 30 Jul 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Diabetic foot ulcer (DFU) patients between the ages of 18 and 60
- Patients of both genders
- Diabetic foot ulcer (DFU) patients whose ulcers are smaller than 15 cm in diameter.
Who cannot join
- • Coagulopathy
- Venous diseases
- Foot Ulcers with underlying Osteomyelitis
- Charcot's joint
- Peripheral Vascular Diseases
- Patients with Wegener's Grade IV
- Involving both feet
- Patients with HIV and Chronic Liver Disease
Trial locations and contacts
1 site in 1 country.
About this study
Conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that VAC dressing gives better results as compared to conventional saline dressing in treating Diabetic Foot Ulcers. This may decrease amputations rate, work load on hospitals, hospital stay, repeated hospital admissions, unemployment and can improve patient's quality of life. Objective of the study was to compare the effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers in terms of granulation tissue formation and wound healing.
Read the detailed description
it was a randomized Controlled Trial done in department of Surgery, Mayo Hospital,vLahore, Pakistan from January 2022 to July 2022. Patients divided in two groups, in the VAC group (Group A), the wound bed was filled with a saline soaked gauze piece after it is thoroughly cleaned. VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall mounted suction device and the pressure was set at -125 mmHg. In the Saline group (Group B), normal saline dressing was given. This consists of placing a saline soaked gauze piece over the wound bed after cleaning the wound. Patients were assessed and followed for wound healing. The primary outcome parameter was time taken to complete wound healing. Secondary outcome parameters were granulation tissue formation using a visual score and complication of bleeding, pain, and infection. Only healthy granulation tissue which appears pink was considered for scoring assessment. Infection was assessed by wound culture sensitivity which was sent every week.
- Conditions
- Diabetic Foot
- Being tested
- Vacuum Assisted Closure, Saline Dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Assisted ClosureDevice
VAC applied after debridement and saline packing
Saline DressingOther
Wound was managed by saline dressing
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Assisted Closure therapy | Experimental | Diabetic wounds managed wit VAC dressing Receives: Device: Vacuum Assisted Closure |
| Saline Dreesing | Experimental | Saline dressing was done in these patients Receives: Other: Saline Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to wound healing
total time for wound healing was assessed.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Model description
- effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
- Investigators
- Adeel Ashiq, MS, Principal investigator, The Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450015
- Sponsor's protocol ID
- adeel6
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vacuum Assisted Closure and Saline Dressing in Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06450015
- Acronym / sponsor ID
- adeel6
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 10 Jun 2024 (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.
Conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that VAC dressing gives better results as compared to conventional saline dressing in treating Diabetic Foot Ulcers. This may decrease amputations rate, work load on hospitals, hospital stay, repeated hospital admissions, unemployment and can improve patient's quality of life. Objective of the study was to compare the effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers in terms of granulation tissue formation and wound healing.
Detailed description
it was a randomized Controlled Trial done in department of Surgery, Mayo Hospital,vLahore, Pakistan from January 2022 to July 2022. Patients divided in two groups, in the VAC group (Group A), the wound bed was filled with a saline soaked gauze piece after it is thoroughly cleaned. VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall mounted suction device and the pressure was set at -125 mmHg. In the Saline group (Group B), normal saline dressing was given. This consists of placing a saline soaked gauze piece over the wound bed after cleaning the wound. Patients were assessed and followed for wound healing. The primary outcome parameter was time taken to complete wound healing. Secondary outcome parameters were granulation tissue formation using a visual score and complication of bleeding, pain, and infection. Only healthy granulation tissue which appears pink was considered for scoring assessment. Infection was assessed by wound culture sensitivity which was sent every week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- effectiveness of Vacuum Assisted Closure therapy with saline dressing in management of diabetic foot ulcers
| Arm | Type | Receives |
|---|---|---|
| Vacuum Assisted Closure therapy | Experimental | Device: Vacuum Assisted ClosureDiabetic wounds managed wit VAC dressing |
| Saline Dreesing | Experimental | Other: Saline DressingSaline dressing was done in these patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Diabetic foot ulcer (DFU) patients between the ages of 18 and 60
Key exclusion criteria (8 listed)
- • Coagulopathy
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 |
|---|---|---|
| Vacuum Assisted ClosureVAC applied after debridement and saline packing | Device | Vacuum Assisted Closure therapy |
| Saline DressingWound was managed by saline dressing | Other | Saline Dreesing |
Primary outcome
time to wound healing
Time frame: 1 month
total time for wound healing was assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No. Not sharing
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Adeel Ashiq, MS principal investigator
The Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Assisted Closure and Saline Dressing in people with Diabetic Foot, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jun 2024. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to wound healing (time frame: 1 month). 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 10 Jun 2024.