Diabetic WoundNCT06153953
A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds
A study testing vacuum device and conventional dressing therapy in people with Diabetic Wound, run by Sohag University.
Trial summary
Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during… Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Wound
- What is being tested?
- vacuum device and conventional dressing therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to May 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure.
Who cannot join
- • Patients with chronic limb ischemia non-palpable distal pulsation.
- Lack of good hemostasis in the wound.
- Patients with malignant ulcers.
- Hepatic patients and patients receiving radio or chemotherapy.
- Wounds over untreated osteomyelitis.
- Wounds with fistulae to organs or body cavities.
- Presence of necrotic tissue.
- Exposed arteries/nerves/anastomotic site/organ
Trial locations and contacts
No sites are listed yet.
osama A abdoabdelraheem, professor contact
About this study
Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)
- Conditions
- Diabetic Wound
- Being tested
- vacuum device, conventional dressing therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum deviceDevice
use of vacuum device in dressing of diabetic wounds
conventional dressing therapyOther
us of conventional dressing with betadine and iruxol in diabetic wounds
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Not described Receives: Device: vacuum device |
| group B | Active comparator | Not described Receives: Other: conventional dressing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of healing
healing progress
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 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 Diabetic WoundStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ahmed Atta, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153953
- Sponsor's protocol ID
- Soh-Med-23-11-01MS
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
PubMed 16291063Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008 Apr;31(4):631-6. doi: 10.2337/dc07-2196. Epub 2007 Dec 27.
PubMed 18162494Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg. 2008 Jun;195(6):782-8. doi: 10.1016/j.amjsurg.2007.06.023. Epub 2008 Mar 26.
PubMed 18355797Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012 May-Jun;20(3):332-41. doi: 10.1111/j.1524-475X.2012.00780.x.
PubMed 22564228
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds
- ClinicalTrials.gov ID
- NCT06153953
- Acronym / sponsor ID
- Soh-Med-23-11-01MS
- Conditions
- Diabetic Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Dec 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.
Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: vacuum device |
| group B | Active comparator | Other: conventional dressing therapy |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure.
Key exclusion criteria (8 listed)
- • Patients with chronic limb ischemia non-palpable distal pulsation.
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 deviceuse of vacuum device in dressing of diabetic wounds | Device | group A |
| conventional dressing therapyus of conventional dressing with betadine and iruxol in diabetic wounds | Other | group B |
Primary outcome
duration of healing
Time frame: 6 months
healing progress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 16291063Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
- Background: PubMed 18162494Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. 2008 Apr;31(4):631-6. doi: 10.2337/dc07-2196. Epub 2007 Dec 27.
- Background: PubMed 18355797Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg. 2008 Jun;195(6):782-8. doi: 10.1016/j.amjsurg.2007.06.023. Epub 2008 Mar 26.
- Background: PubMed 22564228Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012 May-Jun;20(3):332-41. doi: 10.1111/j.1524-475X.2012.00780.x.
- 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.
osama A abdoabdelraheem, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing vacuum device and conventional dressing therapy in people with Diabetic Wound, run by Sohag University.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mohsen A ahmed attaelkareem, resident (01063846084, mohsenatta@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of healing (time frame: 6 months). 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 NCT06153953, 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 1 Dec 2023.