REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)

NCT ID: NCT05413746

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2020-06-06

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 the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.

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 evolution of the disease. The high rate of recurrence of these lesions and their high mortality rate make this pathology an important health problem with high health, economic and social repercussions. Diabetic foot injury is defined as any infection, ulceration, and/or destruction of the deep tissues of the foot associated with neurological, vascular, and metabolic disorders (sustained hyperglycemia) in the lower limbs of people with diabetes. Between 40% and 70% of lower-limb amputations occur in the diabetic population, and in up to 85% of cases, the triggering factor is ulcer, associated with infection and gangrene. The incidence of a new episode after an amputation is around 50% 5 years later.

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 the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.

Conditions

Diabetes Mellitus; Foot Ulcer; Neuroischemic Foot Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antioxidant dressing (active product)

Wound bed debridement, Antioxidant dressing (active product) application in the wound bed, covered with secondary dressing.

Device: Reoxcare®

Group Type: EXPERIMENTAL

Reoxcare antioxidant dressing

Intervention Type: DEVICE

After wound cleaning activities, wound bed debridement if necessary and elimination of hyperkeratotic edges, wounds are treated with Reoxcare as primary dressing and the approppriate secondary dressing for adequate exudates management

Interventions

Reoxcare antioxidant dressing

After wound cleaning activities, wound bed debridement if necessary and elimination of hyperkeratotic edges, wounds are treated with Reoxcare as primary dressing and the approppriate secondary dressing for adequate exudates management

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with wounds with clinical signs of local infection
• Intolerance to the components of the product under study.
• Uncontrolled diabetes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Cruces

OTHER

Sponsor Role: collaborator

Histocell, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andima Basterretxea, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Cruces

Locations

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Histocell

Derio, Vizcaya, Spain

Countries

Spain

References

Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.

Reference Type: BACKGROUND

PMID: 26140672 (View on PubMed)

Castro B, Bastida FD, Segovia T, Lopez Casanova P, Soldevilla JJ, Verdu-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742.

Reference Type: BACKGROUND

PMID: 29244974 (View on PubMed)

Other Identifiers

REOXCARE.DFU

Identifier Type: -

Identifier Source: org_study_id