Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633642
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2020-10-30
Brief Title:
Ultrasound Assisted Wound Debridement UAW Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers DFU
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
Cellular Proliferation Dermal Repair and Microbiological Effectiveness of Ultrasound Assisted Wound Debridement UAW Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers DFU A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgicalsharp wound debridement A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period
Detailed Description:
2 Methods
21 Trial design
A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019 The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos Madrid Spain CP - CI 16484-P Each patient provided written informed consent before inclusion
21 Intervention
Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period
Soft tissue punch biopsies 3mm were taken after wound debridement sessions at week zero and week six
22 Follow-up Patients were followed-up for 6 months after inclusion During the follow-up period the investigators recorded ulcer healing Ulcer healing was defined as complete epithelialization without any sustained drainage up to 24 weeks after the end of the study follow-up
23 Sample size The sample size was calculated using the Granmo v12 program Municipal Institute of Medical Research Barcelona Spain httpswwwimimcatofertadeserveissoftware-publicgranmo Therefore we analyzed 51 patients 24 in surgical group and 27 en UAW group with an alpha of 005 and a statistical power of 080
24 Randomization A computer-generated random number table was used to carry out the randomization of the patients into the two groups by an investigator who was blinded to the identity of the participants
25 Blinding None of the participants care providers and outcome adjudicators was blinded to the interventions after assignment
26 Statistical Analysis Statistical analysis was performed using SPSS for IOs version 210 SPSS Inc Chicago IL USA The assumption of normality of all continuous variables was verified using the Kolmogorov-Smirnov test Statistical differences between groups were calculated using the Chi-Square test and where appropriate Fishers exact test for categorical variables The Mann-Whitney U test was performed for abnormally distributed quantitative parameters and Students t-test was performed for quantitative variables that were distributed normally The criteria of p 005 was accepted as statistically significant with a confidence interval of 95
This study was conducted in accordance with the Declaration of Helsinki 2013 revision and followed all local laws and regulations in clinical research investigations in patients
21 Trial design
A randomized and controlled parallel clinical trial was performed involving outpatients with complicated DFU that were admitted to specialized diabetic foot unit between November 2017 to December 2019 The study protocol received full approval from the Ethics Committee of the Hospital Clínico San Carlos Madrid Spain CP - CI 16484-P Each patient provided written informed consent before inclusion
21 Intervention
Participants were randomized and assigned to receive either surgical debridement or UAW debridement every week during a six-week treatment period
Soft tissue punch biopsies 3mm were taken after wound debridement sessions at week zero and week six
22 Follow-up Patients were followed-up for 6 months after inclusion During the follow-up period the investigators recorded ulcer healing Ulcer healing was defined as complete epithelialization without any sustained drainage up to 24 weeks after the end of the study follow-up
23 Sample size The sample size was calculated using the Granmo v12 program Municipal Institute of Medical Research Barcelona Spain httpswwwimimcatofertadeserveissoftware-publicgranmo Therefore we analyzed 51 patients 24 in surgical group and 27 en UAW group with an alpha of 005 and a statistical power of 080
24 Randomization A computer-generated random number table was used to carry out the randomization of the patients into the two groups by an investigator who was blinded to the identity of the participants
25 Blinding None of the participants care providers and outcome adjudicators was blinded to the interventions after assignment
26 Statistical Analysis Statistical analysis was performed using SPSS for IOs version 210 SPSS Inc Chicago IL USA The assumption of normality of all continuous variables was verified using the Kolmogorov-Smirnov test Statistical differences between groups were calculated using the Chi-Square test and where appropriate Fishers exact test for categorical variables The Mann-Whitney U test was performed for abnormally distributed quantitative parameters and Students t-test was performed for quantitative variables that were distributed normally The criteria of p 005 was accepted as statistically significant with a confidence interval of 95
This study was conducted in accordance with the Declaration of Helsinki 2013 revision and followed all local laws and regulations in clinical research investigations in patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None