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De klinische studie NCT07147790 (SNIPS-FOOT) voor Ischemia Limb, Diabetes mellitus is inschrijving op uitnodiging. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kafrelsheikh UniversiteitComparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management (SNIPS-FOOT) 100 Gerandomiseerd
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De klinische studie NCT07147790 (SNIPS-FOOT) is een observationeel studie bij Ischemia Limb, Diabetes mellitus met de status inschrijving op uitnodiging. Het doel is om 100 deelnemers te includeren vanaf 5 mei 2024. De studie wordt geleid door Kafrelsheikh Universiteit en de voltooiing is gepland op 10 december 2025. Laatste update op ClinicalTrials.gov: 11 september 2025.
Beknopte samenvatting
This was a prospective, parallel-group, randomized controlled trial conducted at the Vascular Surgery Department of Kafrelsheikh University Hospital, Egypt. The study was approved by the Institutional Review Board and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Patients were eligible if they were ≥18 years of age, had diabetes mellitus with c...
Toon meerOfficiële titel
Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management
Aandoeningen
Ischemia LimbDiabetes mellitusAndere studie-ID's
- SNIPS-FOOT
- KFSIRB200-252
- [email protected] (Overige identificatiecode) (kafrelsheikh university)
NCT-ID
Startdatum (Werkelijk)
2024-05-05
Laatste update geplaatst
2025-09-11
Verwachte einddatum
2025-12-10
Inschrijving (Geschat)
100
Studietype
Observationeel
Status
Inschrijving op uitnodiging
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
two groups A and B groups A total of 100 patients were randomized into two equal groups using a computer-generated list with sealed opaque envelopes. Twelve patients were excluded post-randomization, resulting in 88 patients (44 per group) for final analysis.
Group A received NPWT integrated with silver nanoparticle spray applied for 15 minutes before NPWT application using foam pre-soaked with the same spray. Group B received standard NPWT ...Toon meer | After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the woun After successful revacularization, We will categorize patients into two groups :
groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a...Toon meer Silver Nanoparticles Irrigant After successful revacularization, We will categorize patients into two groups :
groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a...Toon meer |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
time to complete wound healingduring | during 1 year follow up period |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
40 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Patient with critical limb ischemia(CLI) Rutherford stage 6 or Fontaine stage 4. Wounds classified as Wagner classification grade 2 to 4.Successful revascularization was confirmed by imaging and clinical assessment.
- 1. Patients with active infection(pus discharge and still need debridement), osteomyelitis.
2. patients who are allergic to silver or any components used in NPWT. 3. patients who are unable to follow up with us. patient
Kafrelsheikh Universiteit95 actieve klinische studies om te verkennenVerantwoordelijke instantie
Mohab Mohamed Abdelfattah Saeed, Hoofdonderzoeker, Lecturer, Kafrelsheikh University
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Kafrelshaykh Governorate
Kafr El Shaykh University, Kafr ash Shaykh, Kafrelshaykh Governorate, 33511, Egypt