ISRCTN23090333
Completed
Not Applicable
Pilot study designed to assess functionality of a low-cost negative pressure wound therapy system in patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps, grafts and surgical incisions
Healyx Labs0 sites15 target enrollmentMay 30, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Healyx Labs
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient is 18 years of age or older
- •2\. Patient presents with an open wound
- •3\. Patient is able to understand study requirements, is willing to undergo subject procedures, provide any required subject feedback, and provide informed consent to participate in the study
Exclusion Criteria
- •1\. Patient who is pregnant or nursing
- •2\. Patient with a non\-survivable wound, life expectancy of 7 days or less
- •3\. Patient’s wound is of malignant or vasculitis origin, or shows presence of necrotic tissue
- •4\. Patient’s wound has active bleeding, exposed blood vessels or organs
- •5\. Patient with wound\-related comorbidities, including diabetic ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Coma, vascular disease, or arthritis
- •6\. Patient currently using medications that cause immune suppression
- •7\. Patient with wound considered too difficult to seal based on location
- •8\. Patient unable to understand study or provide informed consent to participate in the study
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A pilot study to investigate the functionality of intra-vaginal glucose sensor in vagina.<br>NL-OMON47792igalli BV5
Completed
Phase 2
A pilot study to investigate the functionality of a glucose sensor device in the human eyeDiabetes type 1insulin-dependent diabetes mellitus10012653NL-OMON46042Medische Hulpmiddelen Industrie6
Completed
Not Applicable
Pilot study for evaluating the implementation of a evidence-based and patient-oriented care concept for the treatment of venous leg ulcers in general practitioner practices (Ulcus Cruris Care)Venous leg ulcersDRKS00024421niversitätsklinikum Heidelberg Abteilung Allgemeinmedizin und Versorgungsforschung40
Not yet recruiting
Not Applicable
Estimation of type of hearing loss using a new Forehead knuckle tapping methodCTRI/2021/01/030777Dr Prem Sagar
Not yet recruiting
Not Applicable
A pilot study to investigate the feasibility of an intervention based on the Arm Activity Tracker in stroke patients.NL-OMON50142Erasmus MC, Universitair Medisch Centrum Rotterdam20