Chronic Wounds Clinical Trial
Official title:
Study of the Concordance Between Skin Oxygen Saturation Measurements Made by an Innovative Non-contact Optical Imaging Device (IPAM) and the Reference Medical Device (Periflux 6000) in Patients With Skin Vascular Disorders or Chronic Wounds
According to international consensus, information on the level of skin oxygenation is necessary for the diagnostic management of chronic wounds. The measurement of transcutaneous partial oxygen pressure (or TcPO2, according to the acronym) is measurable with a medical device that uses a Clark electrode. Since the medical device in question is expensive and the measurement time-consuming (approximately 45 minutes per patient), the TcPO2 is only rarely accessible (in hospital medicine as in nursing homes) and is therefore not predominant in the clinical decision. The clinical decision is currently mainly based on the result of the ankle blood pressure measurement, which is readily available. The main objective is to study, from the same skin surfaces (same localization of skin sites and same dimensions of each surface in cm²), in patients with cutaneous vascular disorders or chronic wounds, the relationship between (i) the transcutaneous oxygen saturation values (expressed as a percentage) by the innovative non-contact optical imaging device under study (IPAM, method to be validated) and (ii) the transcutaneous partial oxygen pressure values (TcPO2) (expressed in millimeters of mercury, mmHg) measured by the reference medical device (Périflux6000, gold standard).
The InnovaTICs Dépendance project, funded by the Grand Region Is, aims to develop a medical device meeting the need to measure quickly and non-invasively the skin oxygen saturation. To do this, a device medical was developed by CRAN (Joint Research Unit of the University of Lorraine and CNRS); its industrial transfer was entrusted to the company SD Innovation to produce the VRPC device for "video-reconstruction of chronic wounds". The VRPC medical device makes it possible to measure skin oxygen saturation by an optical (atraumatic) and non-contact (non-invasive) method, more quickly than the current method proposes. The capacity of the VRPC device to measure in vivo variations in skin oxygen saturation was confirmed by carrying out measurements on healthy volunteers. The measured values made it possible to show that the VRPC device was able to detect the difference in skin oxygen saturation between the skin covering a "healthy" finger and the skin covering the same finger but after a tourniquet had been placed at the base of the first phalanx of the finger (data not published). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01442103 -
Clinical Utility of a New Silver Gel for Use on Chronic Wounds
|
N/A | |
| Completed |
NCT00425178 -
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
|
Phase 1 | |
| Not yet recruiting |
NCT04411264 -
Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
|
N/A | |
| Recruiting |
NCT03882983 -
Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
|
Phase 1 | |
| Completed |
NCT04903366 -
Absorption and Safety of Topical Timolol to Treat Chronic Wounds
|
||
| Not yet recruiting |
NCT05491291 -
Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique
|
N/A | |
| Completed |
NCT01572376 -
Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
|
Phase 1/Phase 2 | |
| Completed |
NCT02053337 -
A RCT to Compare Performance of Two Foam Dressings on Patient Well-being Related Endpoints.
|
N/A | |
| Completed |
NCT02519166 -
Characterisation of Biofilm of the Chronic Wounds
|
N/A | |
| Completed |
NCT04320628 -
Randomized Double-Blind Controlled Clinical Trial
|
N/A | |
| Completed |
NCT04342767 -
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
|
||
| Not yet recruiting |
NCT06306716 -
Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds
|
||
| Not yet recruiting |
NCT05493943 -
P.E.M.F. Therapy of Chronic Wounds
|
N/A | |
| Completed |
NCT01881815 -
Swab Sample Collection for the Detection of Bacterial Proteases
|
N/A | |
| Completed |
NCT05764226 -
Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for the Treatment of Chronic Wounds
|
N/A | |
| Completed |
NCT03678636 -
WOUNDCHEK Bacterial Status Benefits Evaluation
|
N/A | |
| Terminated |
NCT03198169 -
A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.
|
N/A | |
| Withdrawn |
NCT04172363 -
Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
|
Phase 3 | |
| Recruiting |
NCT00535548 -
Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
|
Phase 1 | |
| Active, not recruiting |
NCT03793062 -
Genetic and Epigenetic Basis of Chronic Wounds
|