Diabetic Foot UlcerNCT04093635
Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer, run by Assiut University.
Trial summary
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Jan 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients diagnosed as DFU from November 2019 to November 2020 at Assiut University Hospital. The patients will divide into two groups: Group I: Those patients that will be treated by NPWT. Group II: Those patients will be treated with standard saline moist wound care and dressing. Each group consists of 20 patients.
Who may be able to join
- Acute and chronic diabetic wounds, pressure ulcers.
- Wagener's Grade I superficial diabetic ulcer.
- Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
- Ischemic wounds after revascularization.
Who cannot join
- - Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
- Wagener's Grade IV, localized gangrene e.g. toe ,heel.
- Wagener's Grade V, extensive gangrene involving the whole foot.
- Septicemia. .
- Gas forming organism.
- Wounds resulting from venous insufficiency.
Show all 9Show fewer
- Peripheral vascular disease (absent distal pulse).
- Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy
- Any other serious pre-existing cardiovascular, pulmonary and immunological disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
- The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.
Read the detailed description
Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.
The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.
Negative-pressure wound therapy is a non-invasive therapy system that employs a 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 container.
An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.
As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.
NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.
Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.
Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Negative Pressure Wound Therapy
- 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 TherapyDevice
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 will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs
| Study group | Role | What they receive |
|---|---|---|
| Group I | Those patients that will be treated by NPWT. Receives: Device: Negative Pressure Wound Therapy | |
| Group II | Those patients will be treated with standard saline moist wound care and dressing. Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of diabetic foot ulcers.
Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ibrahim Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093635
- Sponsor's protocol ID
- VAC in DFUs
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iheozor-Ejiofor Z, Newton K, Dumville JC, Costa ML, Norman G, Bruce J. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7(7):CD012522. doi: 10.1002/14651858.CD012522.pub2.
PubMed 29969521Liu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Ther Clin Risk Manag. 2017 Apr 18;13:533-544. doi: 10.2147/TCRM.S131193. eCollection 2017.
PubMed 28458556James 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 31007506Borys S, Hohendorff J, Koblik T, Witek P, Ludwig-Slomczynska AH, Frankfurter C, Kiec-Wilk B, Malecki MT. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. 2018 Dec;62(3):611-616. doi: 10.1007/s12020-018-1707-0. Epub 2018 Aug 11.
PubMed 30099674Hu X, Lian W, Zhang X, Yang X, Jiang J, Li M. Efficacy of negative pressure wound therapy using vacuum-assisted closure combined with photon therapy for management of diabetic foot ulcers. Ther Clin Risk Manag. 2018 Oct 25;14:2113-2118. doi: 10.2147/TCRM.S164161. eCollection 2018.
PubMed 30498354
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04093635
- Acronym / sponsor ID
- VAC in DFUs
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 18 Sep 2019 (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.
Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
- The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.
Detailed description
Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.
The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.
Negative-pressure wound therapy is a non-invasive therapy system that employs a 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 container.
An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.
As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.
NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.
Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.
Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Device: Negative Pressure Wound TherapyThose patients that will be treated by NPWT. |
| Group II | – | Device: Negative Pressure Wound TherapyThose patients will be treated with standard saline moist wound care and dressing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients diagnosed as DFU from November 2019 to November 2020 at Assiut University Hospital. The patients will divide into two groups: Group I: Those patients that will be treated by NPWT. Group II: Those patients will be treated with standard saline moist wound care and dressing. Each group consists of 20 patients.
Key inclusion criteria (4 listed)
- Acute and chronic diabetic wounds, pressure ulcers.
- Wagener's Grade I superficial diabetic ulcer.
- Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
- Ischemic wounds after revascularization.
Key exclusion criteria (9 listed)
- - Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
- Wagener's Grade IV, localized gangrene e.g. toe ,heel.
- Wagener's Grade V, extensive gangrene involving the whole foot.
- Septicemia. .
- Gas forming organism.
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 TherapyVAC 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 will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs | Device | Group I, Group II |
Primary outcome
Management of diabetic foot ulcers.
Time frame: one year
Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 29969521Iheozor-Ejiofor Z, Newton K, Dumville JC, Costa ML, Norman G, Bruce J. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7(7):CD012522. doi: 10.1002/14651858.CD012522.pub2.
- Background: PubMed 28458556Liu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Ther Clin Risk Manag. 2017 Apr 18;13:533-544. doi: 10.2147/TCRM.S131193. eCollection 2017.
- 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.
- Background: PubMed 30099674Borys S, Hohendorff J, Koblik T, Witek P, Ludwig-Slomczynska AH, Frankfurter C, Kiec-Wilk B, Malecki MT. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. 2018 Dec;62(3):611-616. doi: 10.1007/s12020-018-1707-0. Epub 2018 Aug 11.
- Background: PubMed 30498354Hu X, Lian W, Zhang X, Yang X, Jiang J, Li M. Efficacy of negative pressure wound therapy using vacuum-assisted closure combined with photon therapy for management of diabetic foot ulcers. Ther Clin Risk Manag. 2018 Oct 25;14:2113-2118. doi: 10.2147/TCRM.S164161. eCollection 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Assiut 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 4 inclusion and 9 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 18 Sep 2019. 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 Abdelrahman Ibrahim (01009842539, abdoibrahim93@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of diabetic foot ulcers. (time frame: one year). 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 NCT04093635, which also lists 5 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 18 Sep 2019.