Chronic Limb Threatening IschemiaNCT05553509
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity
An observational study of Chronic Limb Threatening Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Limb Threatening Ischemia
- What is being tested?
- PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: On the other hand we can consider patients as Borderline ischemia/ Boarderline Vascularity with (Rutherford Grade "I" Categories "2\&3) when they have a borderline ankle systolic pressure
Who may be able to join
- Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2\&3") when they have a borderline ankle systolic pressure
Who cannot join
- All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.
- Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.
- Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of vascular surgery - Assiut University Hospital
Asyut, Asyut Governorate, 71515
About this study
Official title: Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity: an Important Consideration of Timing of Revascularization
Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA
Read the detailed description
Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups
- Conditions
- Chronic Limb Threatening Ischemia
- Being tested
- PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PER CUTANEOUS TRANSLUMINAL ANGIOPLASTYOther
Also called REVASCULARIZATION
SURGICAL DEBRIDEMNT
| Study group | Role | What they receive |
|---|---|---|
| ANGIOPLASTY GROUP | All patients undergoing PTA are going to be classified according to GLASS staging system Receives: Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY | |
| DEBRIDEMENT GROUP | The most commonly used technique for diabetic foot ulcers is sharp or surgical debridement using a scalpel, tissue forceps or similar instruments. It should be sufficiently extensive to remove all infected and necrotic tissue; Receives: Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
- Observe the timing to complete wound healing in both cohorts those with Debridement only \& those with Debridment plus PTA
- Observe the Rate of limb salvage in both groups
Measured: 1 YEAR
Secondary outcomes (1)
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
1-Observe incidence of MACE In both cohorts Observe necessity for further interventions in both cohorts 3-Observe the length of hospital stay in both groups
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2023
- Primary completion1 Nov 2024
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb Threatening IschemiaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ayman Hussien Shaamash, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553509
- Sponsor's protocol ID
- AST-KASH-ENDO
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity: an Important Consideration of Timing of Revascularization
- ClinicalTrials.gov ID
- NCT05553509
- Acronym / sponsor ID
- AST-KASH-ENDO
- Conditions
- Chronic Limb Threatening Ischemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Sep 2022 (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.
Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA
Detailed description
Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANGIOPLASTY GROUP | – | Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTYAll patients undergoing PTA are going to be classified according to GLASS staging system |
| DEBRIDEMENT GROUP | – | Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTYThe most commonly used technique for diabetic foot ulcers is sharp or surgical debridement using a scalpel, tissue forceps or similar instruments. It should be sufficiently extensive to remove all infected and necrotic tissue; |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- On the other hand we can consider patients as Borderline ischemia/ Boarderline Vascularity with (Rutherford Grade "I" Categories "2\&3) when they have a borderline ankle systolic pressure
Key inclusion criteria (1 listed)
- Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2\&3") when they have a borderline ankle systolic pressure
Key exclusion criteria (3 listed)
- All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.
- Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.
- Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity
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 |
|---|---|---|
| PER CUTANEOUS TRANSLUMINAL ANGIOPLASTYAlso: REVASCULARIZATIONSURGICAL DEBRIDEMNT | Other | ANGIOPLASTY GROUP, DEBRIDEMENT GROUP |
Primary outcome
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
Time frame: 1 YEAR
1. Observe the timing to complete wound healing in both cohorts those with Debridement only \& those with Debridment plus PTA 2. Observe the Rate of limb salvage in both groups
1 secondary outcome
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
Time frame: 1 YEAR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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?
An observational study of Chronic Limb Threatening Ischemia, run by Assiut 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity (time frame: 1 YEAR). 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 26 Nov 2024.