Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial
Introduction Diabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preced...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e062344.full |
| _version_ | 1811181849754468352 |
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| author | Stig Brorson Sahar Moeini Hans Gottlieb Tue Smith Jørgensen Thomas Vedste Aagaard Maj Raundrup Kornø Malene Ringholm Bæk Larsen |
| author_facet | Stig Brorson Sahar Moeini Hans Gottlieb Tue Smith Jørgensen Thomas Vedste Aagaard Maj Raundrup Kornø Malene Ringholm Bæk Larsen |
| author_sort | Stig Brorson |
| collection | DOAJ |
| description | Introduction Diabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preceding feasibility trial with promising results, facilitated this trial that aims to study the effect of a novel simple treatment, called inforatio technique, which may promote healing of DFUs. The inforatio technique is a minimally invasive procedure where small cuts are made on wound beds with punch biopsy tools.Methods and analysis This multicentre randomised clinical trial will be conducted at outpatient clinics at Zealand University Hospital, Herlev University Hospital, Slagelse Hospital and Nykoebing Falster Hospital. 100 participants will be included and randomised in a 1:1 ratio to either a control group that receives usual care or an intervention group that receives both usual care and the inforatio technique.The primary outcome is complete healing evaluated on digital images by blinded observers. It is not possible to blind participants or the outpatient clinic staff because the inforatio technique is visible in wound beds after application. Change in EQ-5D-5L (EuroQoL-5 Dimension- 5 Level) Visual Analogue Scale Score and Wound-QoL Global Score from baseline to end of follow-up are secondary outcomes.Ethics and dissemination Ethics approval has been granted by the Danish National Committee on Health Research Ethics on 15 December 2021 (approval ID: SJ-904). Trial results are planned to be published in a high-impact peer-reviewed journal.Trial registration number NCT05189470. |
| first_indexed | 2024-04-11T09:23:45Z |
| format | Article |
| id | doaj.art-9011581842d24aaeb91da7dbf6059452 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T09:23:45Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-9011581842d24aaeb91da7dbf60594522022-12-22T04:32:05ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-062344Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trialStig Brorson0Sahar Moeini1Hans Gottlieb2Tue Smith Jørgensen3Thomas Vedste Aagaard4Maj Raundrup Kornø5Malene Ringholm Bæk Larsen6Department of Orthopaedic Surgery, Zealand University Hospital Koge, Koge, DenmarkDepartment of Orthopaedic Surgery, Zealand University Hospital Koge, Koge, DenmarkDepartment of Orthopaedic Surgery, Herlev Hospital, Herlev, DenmarkDepartment of Orthopaedic Surgery, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Physical and Occupational Therapy, Holbaek Hospital, Holbaek, DenmarkDepartment of Orthopaedic Surgery, Nykoebing Falster Hospital, Nykoebing, DenmarkDepartment of Orthopaedic Surgery, Zealand University Hospital Koge, Koge, DenmarkIntroduction Diabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preceding feasibility trial with promising results, facilitated this trial that aims to study the effect of a novel simple treatment, called inforatio technique, which may promote healing of DFUs. The inforatio technique is a minimally invasive procedure where small cuts are made on wound beds with punch biopsy tools.Methods and analysis This multicentre randomised clinical trial will be conducted at outpatient clinics at Zealand University Hospital, Herlev University Hospital, Slagelse Hospital and Nykoebing Falster Hospital. 100 participants will be included and randomised in a 1:1 ratio to either a control group that receives usual care or an intervention group that receives both usual care and the inforatio technique.The primary outcome is complete healing evaluated on digital images by blinded observers. It is not possible to blind participants or the outpatient clinic staff because the inforatio technique is visible in wound beds after application. Change in EQ-5D-5L (EuroQoL-5 Dimension- 5 Level) Visual Analogue Scale Score and Wound-QoL Global Score from baseline to end of follow-up are secondary outcomes.Ethics and dissemination Ethics approval has been granted by the Danish National Committee on Health Research Ethics on 15 December 2021 (approval ID: SJ-904). Trial results are planned to be published in a high-impact peer-reviewed journal.Trial registration number NCT05189470.https://bmjopen.bmj.com/content/12/9/e062344.full |
| spellingShingle | Stig Brorson Sahar Moeini Hans Gottlieb Tue Smith Jørgensen Thomas Vedste Aagaard Maj Raundrup Kornø Malene Ringholm Bæk Larsen Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial BMJ Open |
| title | Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial |
| title_full | Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial |
| title_fullStr | Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial |
| title_full_unstemmed | Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial |
| title_short | Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial |
| title_sort | inforatio technique to promote wound healing of diabetic foot ulcers study protocol for a parallel group evaluator blinded randomised clinical trial |
| url | https://bmjopen.bmj.com/content/12/9/e062344.full |
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