Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale
Abstract
:1. Introduction
2. Materials and Methods
2.1. Conduct of the Study
- Week 7: patients come to the hospital for the investigator to assess wound progress.
- Week 16: end of study visit after the last application of Kerecis Omega3 Wound. An HbA1c measurement will be collected.
- Week 20: patients come to the hospital for the investigator to assess the progress of the wound.
- Week 24: at the end of the two-month follow-up period an HbA1c measurement will be collected.
2.2. Patient Monitoring
2.3. Photography
- i.
- Has the wound changed its grade, i.e., have the granulations covered bone and tendon? Answered by clinician since the answer is dependent on probing to bone.
- ii.
- Is the wound ready for standard of care only, to commence healing? Answered by clinician and blinded panel of clinicians.
- iii.
- Would a split thickness skin graft be a logical next intervention? Answered by blinded panel only.
2.4. Statistical Methods
- ▪
- H0: no difference in the percentage of patients cured with complete epithelialization at 16 weeks between Kerecis Omega3 Wound and the SOC.
- ▪
- H1: a percentage difference in the number of patients cured with complete epithelialization at 16 weeks between Kerecis Omega3 Wound and SOC.
- ▪
- It is expected that 30% of patients will have healed with complete epithelialization at 16 weeks in the SOC group [see point below].
- ▪
- A 20% improvement with Kerecis Omega3 Wound (i.e., 50% of patients healed) would be considered clinically significant.
- ▪
- A Fisher’s exact conditional test with a two-sided significance level of 0.05 will have 80% power to detect the difference between a Group 1 proportion of 0.3 and a Group 2 proportion of 0.5 for a size d sample in each group of 90.
- ▪
- Assuming an attrition rate of 10%, 180 patients (=190/0.9) will need to be randomized in this trial.
3. Discussion
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Dardari, D.; Potier, L.; Sultan, A.; Francois, M.; M’Bemba, J.; Bouillet, B.; Chaillous, L.; Kessler, L.; Carlier, A.; Jalek, A.; et al. Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale. Medicina 2022, 58, 1775. https://doi.org/10.3390/medicina58121775
Dardari D, Potier L, Sultan A, Francois M, M’Bemba J, Bouillet B, Chaillous L, Kessler L, Carlier A, Jalek A, et al. Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale. Medicina. 2022; 58(12):1775. https://doi.org/10.3390/medicina58121775
Chicago/Turabian StyleDardari, Dured, Louis Potier, Ariane Sultan, Maude Francois, Jocelyne M’Bemba, Benjamin Bouillet, Lucy Chaillous, Laurence Kessler, Aurelie Carlier, Abdulkader Jalek, and et al. 2022. "Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study): An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale" Medicina 58, no. 12: 1775. https://doi.org/10.3390/medicina58121775