Negative-Pressure Wound TherapyNCT05716503
Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds
A study testing Negative Pressure Wound Therapy (NPWT) and Ordinary dressings with antibiotic ointment and gauze in people with Negative-Pressure Wound Therapy and Diabetic Foot, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Negative-Pressure Wound Therapy, Diabetic Foot
- What is being tested?
- Negative Pressure Wound Therapy (NPWT) and Ordinary dressings with antibiotic ointment and gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to Apr 2024
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group 20-75 years.
- Patients with diabetic foot wounds who are scheduled for skin grafting.
Who cannot join
- Age <20 years or > 75 years.
- An obvious septicemia.
- Foot osteomyelitis.
- Ulcer resulting from venous insufficiency.
- Features of malignant ulcer.
- Patients being treated with corticosteroids, immunosuppressive drugs.
- Any other serious pre-existing cardiovascular, pulmonary or immunological disease.
Trial locations and contacts
1 site in 1 country.
Gamal Y Elsayed, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Hady K Elkhayat, Resident, dr.hady.94@gmail.com
About this study
The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.
Read the detailed description
Negative pressure wound therapy is a new noninvasive technique for treating open wounds. It works by removing fluid from the wound bed, reducing edema, and encouraging the growth and perfusion of new granulation tissue.
Vacuum-Assisted Closure device (VAC) helps to remove fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. Vacuum-assisted closure (VAC) can provide stable and persistent negative pressure, and there are several modes to choose from.
VAC has played an important role in helping to close wounds, controlling infection, promoting angiogenesis, increasing blood flow, and promoting granulation tissue growth in wounds. It is now widely applied in all kinds of acute, chronic, and special wounds with good therapeutic results. However, there is a need to pay attention to contraindications and complications of VAC when it is used, avoiding secondary damage due to improper treatment.
- Conditions
- Negative-Pressure Wound Therapy, Diabetic Foot
- Being tested
- Negative Pressure Wound Therapy (NPWT), Ordinary dressings with antibiotic ointment and gauze
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (NPWT)Device
Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting.
Ordinary dressings with antibiotic ointment and gauzeOther
Patients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) | Experimental | Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. Receives: Device: Negative Pressure Wound Therapy (NPWT) |
| Control group (B) | Experimental | Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting. Receives: Other: Ordinary dressings with antibiotic ointment and gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period of hospitalization.
Number of days of patient hospitalization before and after grafting
Measured: 2 weeks
Time of complete healing
Number of days needed for each patient for complete healing after operation
Measured: 1 month
Functional outcome
Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility
Measured: 5 months
Patient satisfaction of aesthetic outcome
Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
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 Negative-Pressure Wound TherapyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will randomly be divided into two groups - study group and control group. Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hady Khaled Elhossiny, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716503
- Sponsor's protocol ID
- Soh-Med-23-01-08
- Status last verified
- Apr 2023
- First submitted
- 18 Jan 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinha K, Chauhan VD, Maheshwari R, Chauhan N, Rajan M, Agrawal A. Vacuum Assisted Closure Therapy versus Standard Wound Therapy for Open Musculoskeletal Injuries. Adv Orthop. 2013;2013:245940. doi: 10.1155/2013/245940. Epub 2013 Jun 26.
PubMed 23878741Lone 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 24765245Ali Z, Anjum A, Khurshid L, Ahad H, Maajid S, Dhar SA. Evaluation of low-cost custom made VAC therapy compared with conventional wound dressings in the treatment of non-healing lower limb ulcers in lower socio-economic group patients of Kashmir valley. J Orthop Surg Res. 2015 Dec 10;10:183. doi: 10.1186/s13018-015-0314-5.
PubMed 26654318Ravari 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 23723599
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT05716503
- Acronym / sponsor ID
- Soh-Med-23-01-08
- Conditions
- Negative-Pressure Wound Therapy, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Feb 2023 (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.
The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.
Detailed description
Negative pressure wound therapy is a new noninvasive technique for treating open wounds. It works by removing fluid from the wound bed, reducing edema, and encouraging the growth and perfusion of new granulation tissue.
Vacuum-Assisted Closure device (VAC) helps to remove fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. Vacuum-assisted closure (VAC) can provide stable and persistent negative pressure, and there are several modes to choose from.
VAC has played an important role in helping to close wounds, controlling infection, promoting angiogenesis, increasing blood flow, and promoting granulation tissue growth in wounds. It is now widely applied in all kinds of acute, chronic, and special wounds with good therapeutic results. However, there is a need to pay attention to contraindications and complications of VAC when it is used, avoiding secondary damage due to improper treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will randomly be divided into two groups - study group and control group. Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. Control group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting.
| Arm | Type | Receives |
|---|---|---|
| Study group (A) | Experimental | Device: Negative Pressure Wound Therapy (NPWT)Study group (A): Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. |
| Control group (B) | Experimental | Other: Ordinary dressings with antibiotic ointment and gauzeControl group (B): Will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age group 20-75 years.
- Patients with diabetic foot wounds who are scheduled for skin grafting.
Key exclusion criteria (7 listed)
- Age <20 years or > 75 years.
- An obvious septicemia.
- Foot osteomyelitis.
- Ulcer resulting from venous insufficiency.
- Features of malignant ulcer.
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 |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT)Patients Will Receive negative pressure wound therapy dressings before skin grafting to prepare the wound bed and after skin grafting. | Device | Study group (A) |
| Ordinary dressings with antibiotic ointment and gauzePatients will Receive once daily dressing with antibiotic ointment and gauze before and after skin grafting. | Other | Control group (B) |
Primary outcome
Period of hospitalization.
Time frame: 2 weeks
Number of days of patient hospitalization before and after grafting
Time of complete healing
Time frame: 1 month
Number of days needed for each patient for complete healing after operation
Functional outcome
Time frame: 5 months
Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility
Patient satisfaction of aesthetic outcome
Time frame: 5 months
Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 23878741Sinha K, Chauhan VD, Maheshwari R, Chauhan N, Rajan M, Agrawal A. Vacuum Assisted Closure Therapy versus Standard Wound Therapy for Open Musculoskeletal Injuries. Adv Orthop. 2013;2013:245940. doi: 10.1155/2013/245940. Epub 2013 Jun 26.
- 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 26654318Ali Z, Anjum A, Khurshid L, Ahad H, Maajid S, Dhar SA. Evaluation of low-cost custom made VAC therapy compared with conventional wound dressings in the treatment of non-healing lower limb ulcers in lower socio-economic group patients of Kashmir valley. J Orthop Surg Res. 2015 Dec 10;10:183. doi: 10.1186/s13018-015-0314-5.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Gamal Y Elsayed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy (NPWT) and Ordinary dressings with antibiotic ointment and gauze in people with Negative-Pressure Wound Therapy and Diabetic Foot, run by Sohag University at 1 site in Egypt.
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 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 12 Apr 2023. 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 Egypt. 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 Hady K Elhossiny, Resident (01096816840, dr_hady_94@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period of hospitalization. (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 NCT05716503, 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 12 Apr 2023.