Ischemia LimbSNIPS-FOOTNCT07147790
Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management
An observational study of Ischemia Limb and Diabete Mellitus, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemia Limb, Diabete Mellitus
- What is being tested?
- 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 and Silver Nanoparticles Irrigant
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2024to 10 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients patient with peripheral arterial disease CLI RUTHERFORD 6,5
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Kafr El Shaykh University
Kafr ash Shaykh, Kafrelshaykh Governorate, 33511
About this study
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 critical limb ischemia (CLI) classified as Rutherford category 6 or Fontaine stage IV, and presented with infected or ischemic foot wounds (Wagner grades 2-4) after successful revascularization confirmed by clinical and imaging evaluation. Exclusion criteria included osteomyelitis, active purulent discharge requiring further debridement, known allergy to silver or NPWT components, and inability to attend follow-up.
Read more
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 after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours.
Primary outcome: time to complete epithelialization. Secondary outcomes: wound size reduction, CRP change, infection rate, pain (VAS), hospital stay, reintervention.
Patients were followed weekly for 1 month and then biweekly for 6 months. CRP, WBC, wound measurements, and VAS were assessed at each visit.
SPSS v26 was used for analysis. Shapiro-Wilk test for normality. Independent t-tests and Mann-Whitney U tests for continuous data. Chi-square or Fisher's exact test for categorical variables. Significance at p < 0.05.
- Conditions
- Ischemia Limb, Diabete Mellitus
- Being tested
- 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, Silver Nanoparticles Irrigant
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 wounDrug
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 normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.
Silver Nanoparticles IrrigantDrug
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 normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue.
| Study group | Role | What they receive |
|---|---|---|
| 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 after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours. Receives: Drug: 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; Drug: Silver Nanoparticles Irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to complete wound healingduring
Measured: during 1 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start5 May 2024
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia LimbStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohab Mohamed Abdelfattah Saeed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147790
- Sponsor's protocol ID
- KFSIRB200-252
- Other IDs
- medical_research@kfs.edu.eg
- Acronym
- SNIPS-FOOT
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management
- ClinicalTrials.gov ID
- NCT07147790
- Acronym / sponsor ID
- SNIPS-FOOT / KFSIRB200-252
- Conditions
- Ischemia Limb, Diabete Mellitus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 29 Aug 2025 (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.
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 critical limb ischemia (CLI) classified as Rutherford category 6 or Fontaine stage IV, and presented with infected or ischemic foot wounds (Wagner grades 2-4) after successful revascularization confirmed by clinical and imaging evaluation. Exclusion criteria included osteomyelitis, active purulent discharge requiring further debridement, known allergy to silver or NPWT components, and inability to attend follow-up.
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 after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours.
Primary outcome: time to complete epithelialization. Secondary outcomes: wound size reduction, CRP change, infection rate, pain (VAS), hospital stay, reintervention.
Patients were followed weekly for 1 month and then biweekly for 6 months. CRP, WBC, wound measurements, and VAS were assessed at each visit.
SPSS v26 was used for analysis. Shapiro-Wilk test for normality. Independent t-tests and Mann-Whitney U tests for continuous data. Chi-square or Fisher's exact test for categorical variables. Significance at p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| two groups A and B groups | – | Drug: 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, Drug: Silver Nanoparticles IrrigantA 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 after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients patient with peripheral arterial disease CLI RUTHERFORD 6,5
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| 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 wounAfter 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 normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue. | Drug | two groups A and B groups |
| Silver Nanoparticles IrrigantAfter 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 normal saline solution for 15 minutes before applying NPWT.). Standard NPWT setting will be used in both groups, with a continuous negative pressure range from 70 to 125 mmHg. Selection criteria for the application of VAC therapy will be presented by calcaneal, dorsal, or plantar foot ulcers with an area of 4.0 and 10.2 cm2. The NPWT dressing will be changed every 3 days. The endpoint of NPWT will be the appearance of healthy granulation tissue. | Drug | two groups A and B groups |
Primary outcome
time to complete wound healingduring
Time frame: during 1 year follow up period
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 11 Sep 2025.
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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.
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 Ischemia Limb and Diabete Mellitus, run by Kafrelsheikh 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 2 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. 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?
time to complete wound healingduring (time frame: during 1 year follow up period). 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 11 Sep 2025.