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| Name | Class |
|---|---|
| Francisco Javier Álvaro Afonso | UNKNOWN |
| David Sevillano Fernández | UNKNOWN |
| Yolanda García Álvarez | UNKNOWN |
| Irene Sanz Corbalan |
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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 surgical/sharp 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.
2. Methods
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Group (UAW group) | Experimental | 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. |
|
| Surgical group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound group | Procedure | Every week during a six-week treatment period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks | Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels). Higher scores mean a better outcome | At week zero and week 6 |
| Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks | Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome. | At week zero and week 6 |
| Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks | Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity) | At week zero and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g) | Tissue samples were weighed and mechanically homogenised in 0.5ml volumes of sterile phosphate buffered saline (PBS, Sigma Aldrich, St Louis, MO). Homogenates were diluted and plated onto Columbia agar (BD, Sparks, MD), Columbia agar supplemented with colistin and nalidixic acid (BD), MacConkey agar (BD), and Sabouraud dextrose agar (BD) using a spiral plater workstation (Don Whitley Scientific, Shipley, UK).The limit of detection was 10 colony-forming units (CFU). Results were expressed as CFU per gram of tissue (CFU/g). Isolated microorganisms were identified by standard criteria and the BBL Crystal identification system (BD). Susceptibility testing of Staphylococcus aureus isolates for oxacillin was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines, using a 30g cefoxitin disc and Mueller-Hinton agar . |
Not provided
Inclusion Criteria:
• Male and female patients ≥18 years old
Exclusion Criteria:
• Chronic renal disease or dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Lázaro Martinez, Professor | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fancisco Javier Álvaro Afonso | Madrid | 28039 | Spain | |||
| José Luis Lázaro Martínez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32176447 | Background | 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. | |
| 22817855 | Background | 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. |
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51 patients met inclusion criteria and were were randomized to treatment
An open-label randomized and controlled parallel clinical trial was performed involving outpatients with complicated Diabetic Foot Ulcer that were admitted to specialized diabetic foot unit between November 2017 to December 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Group (UAW Group) | 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. Every week during 6 weeks |
| FG001 | Surgical Group | Surgical debridement involved removal of all necrotic and devitalized tissue that was incompatible with healing, as well as surrounding callus. Every week during 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Neo-angiogenesis (Microvessel Density) at 6 Weeks | Sections of tissue were immunohistochemically-stained with the CD31 marker. Light microscopy was used to count the number of microvessels/endothelial cells in a standardized grid, with the results expressed as microvessel density (Leica DMD 800 morphometric system). Microvessel density was scored according to the following scale: 0 (absent), 1 (low, at least one microvessel), 2 (moderate) and 3 (more than two micro vessels). Higher scores mean a better outcome | Posted | Mean | Standard Deviation | score on a scale | At week zero and week 6 |
|
6 months after inclusion
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration. |
Not provided
Not provided
Future trials may also evaluate efficiency or cost-effectiveness of both treatments
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Javier Álvaro Afonso | Diabetic Foot Unit, Clínica Universitaria de Podología, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain | 913-941-502 | +34 | alvaro@ucm.es |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2020 | Apr 27, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D006965 | Hyperplasia |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
| UNKNOWN |
| Esther García Morales | UNKNOWN |
A randomized and controlled parallel clinical trial
Not provided
Not provided
Not provided
| Surgical group |
| Procedure |
Every week during a six-week treatment period |
|
| At week zero and week 6 |
| Wound Score at 6 Weeks | Wound bed tissue was evaluated for presence, quality, and consistency of granulation tissue using a validated wound scoring system, with scores ranging between a minimum of zero points and maximum of seven points. Higher scores mean a better outcome. | Six weeks |
| Wound Size | A planimetric measurements of wound size were conducted using Visitrak (Smith & Nephew, Hull, UK), with the area of the lesion determined with an approximation of ±5mm2 | 6 weeks |
| Madrid |
| 28039 |
| Spain |
| 21739682 | Background | Kingsley A, Lewis T, White R. Debridement and wound biofilms. J Wound Care. 2011 Jun;20(6):286. No abstract available. |
| 32058848 | Background | Swanson T, Lazaro-Martinez JL, Braumann C, Kirchhoff JB, Gachter B, van Acker K. Ultrasonic-assisted wound debridement: report from a closed panel meeting. J Wound Care. 2020 Feb 2;29(2):128-135. doi: 10.12968/jowc.2020.29.2.128. |
| 32176450 | Background | 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. |
| 29738301 | Background | 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. |
| 15102020 | Background | Altland OD, Dalecki D, Suchkova VN, Francis CW. Low-intensity ultrasound increases endothelial cell nitric oxide synthase activity and nitric oxide synthesis. J Thromb Haemost. 2004 Apr;2(4):637-43. doi: 10.1111/j.1538-7836.2004.00655.x. |
| 21200279 | Background | Driver VR, Yao M. Discussion. Current status of the use of modalities in wound care: electrical stimulation and ultrasound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:103S-104S. doi: 10.1097/PRS.0b013e3182050c35. No abstract available. |
| 16234574 | Background | 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. |
| 21649783 | Background | 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. |
| 9589255 | Background | 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. |
| 22619242 | Background | 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. |
| 18663232 | Background | 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. |
| 21430002 | Background | Tan T, Shaw EJ, Siddiqui F, Kandaswamy P, Barry PW, Baker M; Guideline Development Group. Inpatient management of diabetic foot problems: summary of NICE guidance. BMJ. 2011 Mar 23;342:d1280. doi: 10.1136/bmj.d1280. No abstract available. |
| 32176441 | Background | Bus SA, Armstrong DG, Gooday C, Jarl G, Caravaggi C, Viswanathan V, Lazzarini PA; International Working Group on the Diabetic Foot (IWGDF). Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3274. doi: 10.1002/dmrr.3274. |
| 30376455 | Background | 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. |
| 18846440 | Background | Wang D, Stockard CR, Harkins L, Lott P, Salih C, Yuan K, Buchsbaum D, Hashim A, Zayzafoon M, Hardy RW, Hameed O, Grizzle W, Siegal GP. Immunohistochemistry in the evaluation of neovascularization in tumor xenografts. Biotech Histochem. 2008 Jun;83(3-4):179-89. doi: 10.1080/10520290802451085. |
| 24604317 | Background | 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. |
| 16286373 | Background | 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. |
| 24141714 | Background | 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. |
| 25158717 | Background | 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. |
| 26079528 | Background | Roper JA, Williamson RC, Bally B, Cowell CAM, Brooks R, Stephens P, Harrison AJ, Bass MD. Ultrasonic Stimulation of Mouse Skin Reverses the Healing Delays in Diabetes and Aging by Activation of Rac1. J Invest Dermatol. 2015 Nov;135(11):2842-2851. doi: 10.1038/jid.2015.224. Epub 2015 Jun 16. |
| 23587975 | Background | 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. |
| 30256750 | Background | 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. |
| 30326972 | Background | 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. |
| 31067172 | Background | 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. |
| BG001 | 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. Ultrasound group: 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. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | 51 outpatients with complicated diabetic foot ulcer were admitted to specialized diabetic foot unit in Spain | Number | participants |
|
| Type Diabetes Mellitus | Count of Participants | Participants |
|
| Duration of Diabetes | Duration of diabetes in years | Mean | Standard Deviation | years |
|
| Glycated hemoglobin | Glycated hemoglobin in mmol/L | Mean | Standard Deviation | mmol/L |
|
| Texas Classification | The University of Texas system for ulcer classification primarily grades ulcers based on depth; each grade is then 'staged', which divides patients who have infected ulcers, those who have ischaemia and those who have both infection and ischaemia. IB: Superficial wound with infection. IIB: Deep wound with infection. ID: Superficial wound with infection and ischaemia. IID: Deep wound with infection and ischaemia. Grades IIB and IID were considered worse outcomes | Count of Participants | Participants |
|
| OG001 | 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. Ultrasound group: 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. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration. |
|
|
|
| Primary | Change From Baseline Collagen Formation (Collagen Content ) at 6 Weeks | Massons's trichome staining was used to differentiate collagen content from other components, such as muscle fibrin and erythrocytes, in tissue samples. Collagen content was scored according to the following scale: 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). Higher scores mean a better outcome. | Posted | Mean | Standard Deviation | score on a scale | At week zero and week 6 |
|
|
|
|
| Primary | Change From Baseline Myofibroblasts Formation (Myofibroblasts Content) at 6 Weeks | Actin staining was used to evaluate the presence of myofibroblasts involved in wound healing. These cells increase in number during wound healing. The number of stained cells was semi-quantitatively analyzed using a 0 - 3 scaling score (0= no myofibroblasts, 1= myofibroblasts in low quantity, 2= myofibroblasts in moderate quantity, 3= myofibroblasts in high quantity) | Posted | Mean | Standard Error | score on a scale | At week zero and week 6 |
|
|
|
|
| Secondary | Comparison of Quantitative Microbiological Analysis (Bacterial Counts Expressed Colony-forming Units Per Gram of Tissue) (CFU/g) | Tissue samples were weighed and mechanically homogenised in 0.5ml volumes of sterile phosphate buffered saline (PBS, Sigma Aldrich, St Louis, MO). Homogenates were diluted and plated onto Columbia agar (BD, Sparks, MD), Columbia agar supplemented with colistin and nalidixic acid (BD), MacConkey agar (BD), and Sabouraud dextrose agar (BD) using a spiral plater workstation (Don Whitley Scientific, Shipley, UK).The limit of detection was 10 colony-forming units (CFU). Results were expressed as CFU per gram of tissue (CFU/g). Isolated microorganisms were identified by standard criteria and the BBL Crystal identification system (BD). Susceptibility testing of Staphylococcus aureus isolates for oxacillin was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines, using a 30g cefoxitin disc and Mueller-Hinton agar . | Posted | Mean | Standard Deviation | Log10 CFU/g | At week zero and week 6 |
|
|
|
|
| Secondary | Wound Score at 6 Weeks | Wound bed tissue was evaluated for presence, quality, and consistency of granulation tissue using a validated wound scoring system, with scores ranging between a minimum of zero points and maximum of seven points. Higher scores mean a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Six weeks |
|
|
|
|
| Secondary | Wound Size | A planimetric measurements of wound size were conducted using Visitrak (Smith & Nephew, Hull, UK), with the area of the lesion determined with an approximation of ±5mm2 | Posted | Mean | Standard Deviation | Centimeter square | 6 weeks |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. Ultrasound group: 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. For wounds measuring >15cm2, the debridement procedure was increased to three minutes. In addition to UAW debridement, a scalpel was used for careful tissue removal, but only if periwound skin exhibited calluses and maceration. | 1 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |