TY - JOUR

T1 - Inforatio technique to promote wound healing of diabetic foot ulcers

T2 - study protocol for a parallel-group, evaluator-blinded, randomised clinical trial

AU - Moeini, Sahar

AU - Gottlieb, Hans

AU - Jørgensen, Tue Smith

AU - Aagaard, Thomas Vedste

AU - Kornø, Maj Raundrup

AU - Larsen, Malene Ringholm Bæk

AU - Brorson, Stig

N1 - Funding Information: This work is supported by The Steno Diabetes Center Sjaelland with a Research Grant from September 2019 (grant number N/A) and by The Region Zealand Research Fund from February 2020 (grant number R19A265B14).

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - DIABETES & ENDOCRINOLOGY

KW - Diabetic foot

KW - Foot & ankle

KW - WOUND MANAGEMENT

U2 - 10.1136/bmjopen-2022-062344

DO - 10.1136/bmjopen-2022-062344

M3 - Journal article

C2 - 36123051

AN - SCOPUS:85138174863

VL - 12

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

M1 - e062344

ER -