Diabetic Foot UlcerNCT04959071
Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
A study testing Vacuum assisted closure VAC vs conventional dressing in people with Diabetic Foot Ulcer and Healing Delayed, run by Bahria University at 1 site in Pakistan.
Trial summary
Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients. DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer, Healing Delayed, Wound; Foot
- What is being tested?
- Vacuum assisted closure VAC vs conventional dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2020to 27 Aug 2020
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. All patients with diabetic foot ulcer of >2 weeks duration. 2. Size of ulcer >3 cm. 3. Well controlled diabetes (HbA1C=6-8.3%). 4. Age 25-65 years. 5. Both genders.
- -
Who cannot join
- Anemic patients (hemoglobin <10 g/dl).
- Patients with history of steroid intake.
- Patients with chronic renal failure (assessed on history and s/creatinine >1.5 mg/dl).
- Patients with history of immunosuppressive therapy.
- Ulcers involving bone as well.
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria University Medical and Dental College Karachi
Karachi, Sindh, 74800
About this study
Official title: Comparison of the Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients.
DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Amongst them VAC provides a new paradigm for diabetic wound dressing. Different studies concluded that DFUs treated with VAC are more likely to heal than CD.
The average healing time varies greatly among different studies conducted. Therefore, we conducted this study to compare the mean healing time of wound after VAC and CD in DFU patients. Based on these results, the method with lesser healing time can be opted for our routine practice guidelines for DFU patient's management protocol.
Read the detailed description
This Randomized controlled trial was conducted at Department of General Surgery, at a tertiary teaching hospital , over duration of six months from 28th February 2020 to 27th August 2020. The calculated sample size was 60 i.e. 30 cases in each group, with 5% level of significance, 80% power of study and taking mean healing time with VAC therapy as 11.366 ± 3.488 days and with conventional dressing as 16.41 ± 3.104 days.6 Non-probability, consecutive sampling technique was used.
After taking permission from ethical review committee , total 60 patients who were presented in outpatient Department of Surgery, at a tertiary care Hospital, Karachi, fulfilling the inclusion criteria was selected. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. In patients undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours. In patients with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups as described in operational definition. This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.
- Conditions
- Diabetic Foot Ulcer, Healing Delayed, Wound; Foot, Diabetes Mellitus
- Being tested
- Vacuum assisted closure VAC vs conventional dressing
- Medical subject headings
- Diabetic Foot, Foot Injuries, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum assisted closure VAC vs conventional dressingProcedure or surgery
Also called Conventional Dressing
In participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours.
In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A included participants who underwent VAC therapy for diabetic Foot ulcers Receives: Procedure: Vacuum assisted closure VAC vs conventional dressing |
| Group B | Active comparator | Group B included participants who underwent conventional dressings for diabetic foot ulcers Receives: Procedure: Vacuum assisted closure VAC vs conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings
participants were assessed for mean healing time of wound after VAC theray and conventional dressing. All participants were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . Healing time was measured in number of days. The start time was the application of first VAC and end time will be the day of wound healing (appearance of granulation tissue over wound as assessed clinically). Similarly start time in conventional dressings was from day of first application of conventional dressing till appearance of granulation tissues over the wound. In both groups mean healing time was compared to see any difference in healing time of both the groups.
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 posted13 Jul 2021
- Study start28 Feb 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomized control trial. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehwish Mooghal , MBBS, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959071
- Sponsor's protocol ID
- VAC vs Conventional Dressing
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabet Foot Ankle. 2014 Apr 8;5. doi: 10.3402/dfa.v5.23345. eCollection 2014.
PubMed 24765245Ravari H, Modaghegh MH, Kazemzadeh GH, Johari HG, Vatanchi AM, Sangaki A, Shahrodi MV. Comparision of vacuum-asisted closure and moist wound dressing in the treatment of diabetic foot ulcers. J Cutan Aesthet Surg. 2013 Jan;6(1):17-20. doi: 10.4103/0974-2077.110091.
PubMed 23723599Lavery LA, Murdoch DP, Kim PJ, Fontaine JL, Thakral G, Davis KE. Negative Pressure Wound Therapy With Low Pressure and Gauze Dressings to Treat Diabetic Foot Wounds. J Diabetes Sci Technol. 2014 Mar;8(2):346-349. doi: 10.1177/1932296813519012. Epub 2014 Feb 18.
PubMed 24876586James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
PubMed 31007506
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
- ClinicalTrials.gov ID
- NCT04959071
- Acronym / sponsor ID
- VAC vs Conventional Dressing
- Conditions
- Diabetic Foot Ulcer, Healing Delayed, Wound; Foot, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 13 Jul 2021 (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.
Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients.
DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Amongst them VAC provides a new paradigm for diabetic wound dressing. Different studies concluded that DFUs treated with VAC are more likely to heal than CD.
The average healing time varies greatly among different studies conducted. Therefore, we conducted this study to compare the mean healing time of wound after VAC and CD in DFU patients. Based on these results, the method with lesser healing time can be opted for our routine practice guidelines for DFU patient's management protocol.
Detailed description
This Randomized controlled trial was conducted at Department of General Surgery, at a tertiary teaching hospital , over duration of six months from 28th February 2020 to 27th August 2020. The calculated sample size was 60 i.e. 30 cases in each group, with 5% level of significance, 80% power of study and taking mean healing time with VAC therapy as 11.366 ± 3.488 days and with conventional dressing as 16.41 ± 3.104 days.6 Non-probability, consecutive sampling technique was used.
After taking permission from ethical review committee , total 60 patients who were presented in outpatient Department of Surgery, at a tertiary care Hospital, Karachi, fulfilling the inclusion criteria was selected. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. In patients undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours. In patients with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups as described in operational definition. This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Vacuum assisted closure VAC vs conventional dressingGroup A included participants who underwent VAC therapy for diabetic Foot ulcers |
| Group B | Active comparator | Procedure: Vacuum assisted closure VAC vs conventional dressingGroup B included participants who underwent conventional dressings for diabetic foot ulcers |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. All patients with diabetic foot ulcer of >2 weeks duration. 2. Size of ulcer >3 cm. 3. Well controlled diabetes (HbA1C=6-8.3%). 4. Age 25-65 years. 5. Both genders.
- -
Key exclusion criteria (6 listed)
- Anemic patients (hemoglobin <10 g/dl).
- Patients with history of steroid intake.
- Patients with chronic renal failure (assessed on history and s/creatinine >1.5 mg/dl).
- Patients with history of immunosuppressive therapy.
- Ulcers involving bone as well.
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 closure VAC vs conventional dressingAlso: Conventional DressingIn participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours. In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily. | Procedure or surgery | Group A, Group B |
Primary outcome
Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings
Time frame: 1 month
participants were assessed for mean healing time of wound after VAC theray and conventional dressing. All participants were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . Healing time was measured in number of days. The start time was the application of first VAC and end time will be the day of wound healing (appearance of granulation tissue over wound as assessed clinically). Similarly start time in conventional dressings was from day of first application of conventional dressing till appearance of granulation tissues over the wound. In both groups mean healing time was compared to see any difference in healing time of both the groups.
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 13 Jul 2021.
- Background: PubMed 24765245Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabet Foot Ankle. 2014 Apr 8;5. doi: 10.3402/dfa.v5.23345. eCollection 2014.
- Background: PubMed 23723599Ravari H, Modaghegh MH, Kazemzadeh GH, Johari HG, Vatanchi AM, Sangaki A, Shahrodi MV. Comparision of vacuum-asisted closure and moist wound dressing in the treatment of diabetic foot ulcers. J Cutan Aesthet Surg. 2013 Jan;6(1):17-20. doi: 10.4103/0974-2077.110091.
- Background: PubMed 24876586Lavery LA, Murdoch DP, Kim PJ, Fontaine JL, Thakral G, Davis KE. Negative Pressure Wound Therapy With Low Pressure and Gauze Dressings to Treat Diabetic Foot Wounds. J Diabetes Sci Technol. 2014 Mar;8(2):346-349. doi: 10.1177/1932296813519012. Epub 2014 Feb 18.
- Background: PubMed 31007506James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 VAC vs conventional dressing in people with Diabetic Foot Ulcer and Healing Delayed, run by Bahria University 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 2 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: finished, as of the sponsor's last update on 13 Jul 2021. 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?
Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959071, which also lists 4 linked publications.
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 13 Jul 2021.