Clinical Trials Logo

Clinical Trial Summary

This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.

Clinical Trial Description

BACKGROUND 15-25% of diabetic patients develop chronic foot ulcers - a serious comorbidity that widely affects quality of life and is associated with increased mortality and morbidity. 50-60% of DFUs become infected, and 20% of patients with infected DFUs undergo lower extremity amputation. Inforatio technique is a novel treatment of DFUs where small cuts are made in wound beds with punch biopsy tools without involving epithelia. The aim is to cause controlled bleeding and initiate an acute inflammatory response that may promote healing. The research group has conducted a preceding feasibility trial that showed promising results (see study by Moeini et al. in the reference list). Inforatio technique may become a supplemental treatment option for diabetic patients worldwide if it shows a beneficial effect on healing. TRIAL AIMS This trial aims to assess whether the proportion of ulcers that heal within 20 weeks is higher when DFUs are treated with inforatio technique in addition to usual wound care compared to treatment with usual wound care alone. RECRUITMENT Patients are eligibility-screened and identified by the investigators and wound care staff when patients visit the recruiting wound outpatient clinics. INCLUSION AND FOLLOW-UP Eligible patients are included if they give their oral and written consent to participate. The baseline trial visit takes place on the day that patients give their consent to participate. The trial comprises a 20-week clinical follow-up. Follow-up visits will be at 3, 6, 9, 12, 16 and 20 weeks after baseline (give or take 7 days for midtrial visits and from 20 to 22 weeks after baseline for the last trial visit). Follow-up end whenever the following appears; 20-week follow-up visit, death, amputation, or the outpatient clinic staff observes healing. The trial will be stopped if the intervention shows an unintended effect or potential harm. RANDOMIZATION Allocation of participants is conducted by block randomization with stratification by center and will be generated with Research Electronic Data Capture (REDCap)©. Block sizes will be randomly alternating between two and four. The allocation will immediately be revealed to the participant and wound care staff. Adequate allocation concealment is ensured by the irreversibility of randomization and the inability to predict the next allocation assignment in RedCap. STATISTICAL ANALYSIS PLAN Baseline characteristics will be reported with appropriate descriptive statistics. The analyses of primary and secondary outcomes will be performed on the intention-to-treat population with participants being analyzed as randomized regardless of the treatment received. Supplementary analyses will be performed on the per-protocol population, which excludes participants with one or more serious protocol violations as defined below: - Participants not receiving their allocated treatment. - Participants with inadequate adherence, which is defined as the following: - Participants that miss more than 3 of the 6 trial visits. - Participants in the intervention group that miss more than 2 of the 4 trial visits where inforatio is applied. Healing will be reported descriptively and a chi squared test will be performed. The primary analysis of the trial will be a logistic regression for proportion of healed ulcers with adjustment for center of recruitment and various baseline characteristics. EQ-5D-5L and Wound-QoL data will be presented descriptively in line with the guidelines for the questionnaires. ANCOVA models adjusting for baseline score will be performed for analysis of change in EQ-5D-5L index score and Wound-QoL global score. Safety outcome will be descriptively reported and analyzed on 'as treated' basis where participants are grouped according to whether they received inforatio technique. Mean time and range from the last inforatio applied to an event is detected will be reported for the intervention group. A statistical comparison between groups will be conducted by chi square test and estimates of relative risk with 95%CI. Inforatio-related adverse events will be descriptively reported. An interim analyses will be performed after 40 participant has completed follow-up. Significance is set at p-value <0.05 and p-values are two-tailed. Underlying statistical assumptions for linear and logistic regressions will be assessed graphically. HANDLING OF MISSING DATA Missing data on primary and secondary outcomes will be handled according to recommendations by Jakobsen et al. (see reference list). If the proportion of missing data on an outcome is <5%, the primary analysis of missing data will be complete-case analyses. If more than 5% data of an outcome is missing, the primary analysis will include missing data imputed by multiple imputation technique and complete case analysis will be performed as a sensitivity analysis. In both cases, a sensitivity analysis will be conducted as best-worst and worst-best analysis for missing data according to definitions by Jakobsen et al. SAMPLE SIZE A meta analysis by Margolis et al. (see reference list) has reported a healing rate of 30.9% (95% CI 26.6-35.1) in 20 weeks for non-infected DFUs that were treated with standard wound care. A healing rate of 60% in 20 weeks was suggested by the preceding feasibility trial when patients receive inforatio technique in addition to usual wound care. When the power is 80% and the alpha-level is 5%, a power calculation gives a sample size of 84 for comparison of two proportions when the outcome proportion is 30% for the control group and the aim is to assess whether the outcome improves with 30 percentage points in the intervention group. To allow an attrition of 20%, the aim is to recruit 100 participants for the trial. ETHICAL CONSIDERATIONS AND RISK ASSESSMENT OF SIDE EFFECTS Inforatio technique is a minimal invasive procedure. Thus, no adverse events are expected as a result of inforatio technique except from a low risk of pain during application. In the preceding feasibility trial, no intervention-related adverse events were observed and participants did not experience pain during application. Furthermore, inforatio technique showed a promising effect on healing. The clinical assessment of the wound care staff, patient preference and patient tolerance is taken into consideration before inforatio technique is applied. If the inforatio technique shows a significant positive effect on healing, it would become of great importance for future patients as a supplemental treatment to standard wound care of DFUs. COMPETING INTERESTS The trial investigators declare that they have no competing interests. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05189470
Study type Interventional
Source Zealand University Hospital
Contact Sahar Moeini, MD
Phone +45 30628222
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date February 2022
Completion date June 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Active, not recruiting NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Active, not recruiting NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Recruiting NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT04452331 - Assessing Open Access Audio N/A
Recruiting NCT04938557 - Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes N/A
Completed NCT01809288 - Identifying Risk for Diabetes and Heart Disease in Women
Completed NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Completed NCT03362528 - Database and Calibration of a Non-invasive Glucose Monitoring Device N/A
Completed NCT02249871 - Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects Phase 1