Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
NCT ID: NCT04633642
Last Updated: 2021-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2017-11-01
2019-12-31
Brief Summary
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Detailed Description
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2.1. 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 (C.P. - C.I. 16/484-P). Each patient provided written informed consent before inclusion.
2.1. 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.
2.2. 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.
2.3. Sample size The sample size was calculated using the Granmo v.12 program (Municipal Institute of Medical Research, Barcelona, Spain) (https://www.imim.cat/ofertadeserveis/software-public/granmo/ ). Therefore, we analyzed 51 patients (24 in surgical group and 27 en UAW group) with an alpha of 0.05 and a statistical power of 0.80.
2.4. 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.
2.5. Blinding None of the participants, care providers, and outcome adjudicators was blinded to the interventions after assignment.
2.6. Statistical Analysis Statistical analysis was performed using SPSS for IOs version 21.0 (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, Fisher's exact test for categorical variables. The Mann-Whitney U test was performed for abnormally distributed quantitative parameters, and Student's t-test was performed for quantitative variables that were distributed normally. The criteria of p \< 0.05 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ultrasound Group (UAW group)
UAW debridement was performed using an UAW SONOCA 185 device (Söring GmbH, Germany). The UAW device generates an ultrasound low frequency of 25kHz and is equipped with three UAW instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth, which ranges from superficial to deep. The UAW instrument piezoelectrically transforms the electrical energy delivered from the UAW device into mechanical oscillations in the sonotrode tip. For most wounds in the UAW group, a two-minute treatment with 40% intensity was performed by holding the sonotrode in contact mode, holding it perpendicular to the wound bed and moving it across in an up-and-down pattern.
Ultrasound group
Every week during a six-week treatment period
Surgical group
All debridement procedures were performed by the same surgeon (J.L.M.), who is specialist in diabetic foot surgery with more than 20 years of experience.
Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus.
Surgical group
Every week during a six-week treatment period
Interventions
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Ultrasound group
Every week during a six-week treatment period
Surgical group
Every week during a six-week treatment period
Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes with levels of HbA1c≤85.8 mmol/mol (10%) within 30 days of the beginning of the study
* Wound stages IB, IIB, ID, and IID according to the University of Texas Diabetic Wound Classification \[11\]
* Wound duration of 1-24 months
* Wound size between 1-30 cm2 after debridement
* Clinical picture of wounds showing mild or moderate infection, according to the criteria of the Infectious Disease Society of America Guidelines \[12\] and the European Wound Management Association (EWMA) \[13\]
* Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI\>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7
Exclusion Criteria
* Non-treated osteomyelitis
* Necrotizing soft tissue infections
* Critical limb ischaemia patients with ABI≤0.5 and ASBP\<70mmHg or \<50mmHg
* Life expectancy \<6 months due to malignant DFU
* Pregnancy and lactation
* Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
* Patients showing local or systemic conditions that may impair tissue repair
18 Years
ALL
No
Sponsors
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Francisco Javier Álvaro Afonso
UNKNOWN
David Sevillano Fernández
UNKNOWN
Yolanda García Álvarez
UNKNOWN
Irene Sanz Corbalan
UNKNOWN
Esther García Morales
UNKNOWN
Universidad Complutense de Madrid
OTHER
Responsible Party
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Jose Luis Lazaro Martinez
Prof.Dr
Principal Investigators
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Lázaro Martinez, Professor
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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Fancisco Javier Álvaro Afonso
Madrid, , Spain
José Luis Lázaro Martínez
Madrid, , Spain
Countries
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References
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Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.
Kim PJ, Steinberg JS. Wound care: biofilm and its impact on the latest treatment modalities for ulcerations of the diabetic foot. Semin Vasc Surg. 2012 Jun;25(2):70-4. doi: 10.1053/j.semvascsurg.2012.04.008.
Kingsley A, Lewis T, White R. Debridement and wound biofilms. J Wound Care. 2011 Jun;20(6):286. No abstract available.
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Rayman G, Vas P, Dhatariya K, Driver V, Hartemann A, Londahl M, Piaggesi A, Apelqvist J, Attinger C, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3283. doi: 10.1002/dmrr.3283.
Lazaro-Martinez JL, Alvaro-Afonso FJ, Garcia-Alvarez Y, Molines-Barroso RJ, Garcia-Morales E, Sevillano-Fernandez D. Ultrasound-assisted debridement of neuroischaemic diabetic foot ulcers, clinical and microbiological effects: a case series. J Wound Care. 2018 May 2;27(5):278-286. doi: 10.12968/jowc.2018.27.5.278.
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Ennis WJ, Foremann P, Mozen N, Massey J, Conner-Kerr T, Meneses P. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. 2005 Aug;51(8):24-39.
Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: a meta-analysis. Wound Repair Regen. 2011 Jul-Aug;19(4):475-80. doi: 10.1111/j.1524-475X.2011.00701.x. Epub 2011 Jun 7.
Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998 May;21(5):855-9. doi: 10.2337/diacare.21.5.855.
Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; American Diabetes Association; American Association of Clinical Endocrinologists. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008 Aug;31(8):1679-85. doi: 10.2337/dc08-9021. No abstract available.
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Tardaguila-Garcia A, Lazaro-Martinez JL, Sanz-Corbalan I, Garcia-Alvarez Y, Alvaro-Afonso FJ, Garcia-Morales E. Correlation between Empirical Antibiotic Therapy and Bone Culture Results in Patients with Osteomyelitis. Adv Skin Wound Care. 2019 Jan;32(1):41-44. doi: 10.1097/01.ASW.0000542527.48815.1f.
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Achar RA, Silva TC, Achar E, Martines RB, Machado JL. Use of insulin-like growth factor in the healing of open wounds in diabetic and non-diabetic rats. Acta Cir Bras. 2014 Feb;29(2):125-31. doi: 10.1590/S0102-86502014000200009.
Wollina U, Schmidt WD, Kronert C, Nelskamp C, Scheibe A, Fassler D. Some effects of a topical collagen-based matrix on the microcirculation and wound healing in patients with chronic venous leg ulcers: preliminary observations. Int J Low Extrem Wounds. 2005 Dec;4(4):214-24. doi: 10.1177/1534734605283001.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Maan ZN, Januszyk M, Rennert RC, Duscher D, Rodrigues M, Fujiwara T, Ho N, Whitmore A, Hu MS, Longaker MT, Gurtner GC. Noncontact, low-frequency ultrasound therapy enhances neovascularization and wound healing in diabetic mice. Plast Reconstr Surg. 2014 Sep;134(3):402e-411e. doi: 10.1097/PRS.0000000000000467.
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Butcher G, Pinnuck L. Wound bed preparation: ultrasonic-assisted debridement. Br J Nurs. 2013 Mar 28-Apr 10;22(6):S36, S38-43. doi: 10.12968/bjon.2013.22.Sup4.S36.
Michailidis L, Bergin SM, Haines TP, Williams CM. A Systematic Review to Compare the Effect of Low-frequency Ultrasonic Versus Nonsurgical Sharp Debridement on the Healing Rate of Chronic Diabetes-related Foot Ulcers. Ostomy Wound Manage. 2018 Sep;64(9):39-46.
Michailidis L, Bergin SM, Haines TP, Williams CM. Healing rates in diabetes-related foot ulcers using low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised controlled trial. BMC Res Notes. 2018 Oct 16;11(1):732. doi: 10.1186/s13104-018-3841-4.
Messa CA 4th, Chatman BC, Rhemtulla IA, Broach RB, Mauch JT, D'Angelantonio AM 3rd, Fischer JP. Ultrasonic debridement management of lower extremity wounds: retrospective analysis of clinical outcomes and cost. J Wound Care. 2019 May 1;28(Sup5):S30-S40. doi: 10.12968/jowc.2019.28.Sup5.S30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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C.P. - C.I. 16/484-P
Identifier Type: -
Identifier Source: org_study_id
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