Status:
COMPLETED
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
Lead Sponsor:
Histocell, S.L.
Collaborating Sponsors:
Hospital de Cruces
Conditions:
Diabetes Mellitus
Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on ...
Detailed Description
The frequency in the appearance of diabetic foot lesions is extremely high; it is estimated that around 15% of people with diabetes will present some compromise at the level of the foot during the evo...
Eligibility Criteria
Inclusion
- Post-surgical diabetic foot ulcers after an amputation process, with the purpose of closure by "secondary intention". There may be prior limb bypass surgery.
- Diabetic foot ulcers with a neuroischemic component
- Ulcers located on the foot, below the malleoli.
- Ulcers without clinical signs of infection at the time of recruitment
- Patients with sufficient physical and health characteristics to be able to respond to treatment and over 18 years of age.
- The patient and/or his/her relative/representative have given their informed consent in writing.
- In the case of several lesions in the same patient that meet the inclusion criteria, select, at the investigator's discretion, the ulcer that can best benefit from the treatment. The rest of the injuries will be treated according to clinical criteria, with the dressings available in the usual clinical practice of the Center or REOXCARE.
Exclusion
- Patients with wounds with clinical signs of local infection
- Intolerance to the components of the product under study.
- Uncontrolled diabetes
- Other ulcers not included in the inclusion criteria.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05413746
Start Date
February 5 2018
End Date
June 6 2020
Last Update
February 29 2024
Active Locations (2)
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1
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain, 48903
2
Histocell
Derio, Vizcaya, Spain, 48160