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

NCT05413746 | Completed

• 1 other identifier: REOXCARE.DFU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Foot Ulcer; Neuroischemic Foot Ulcer

Keywords

Wound care; Diabetic foot ulcer; Antioxidants

Outcome Measures

Primary Outcomes (2)

• Changes in Granulation tissue in the wound bed

  The percentage of granulation tissue in the wound bed is estimated by the clinicians in each week of Reoxcare treatment, At baseline and every week

  At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week

• Changes in wound size

  The difference in wound area between first and last dressing Reoxcare treatment

  At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week

Secondary Outcomes (2)

• Number of completely healed wounds

  At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week

• Time to removal of non-viable tissue from wound bed

  At baseline, after 1 week, after 2 week, after 3 week, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks and after 8 week

Study Arms (1)

Antioxidant dressing (active product)

EXPERIMENTAL

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

Device: Reoxcare antioxidant dressing

Interventions

Reoxcare antioxidant dressing 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

Antioxidant dressing (active product)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Histocell, S.L.: lead
• Hospital de Cruces: collaborator

Study Sites (2)

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Histocell

Derio, Vizcaya, 48160, Spain

Location

Related Publications (2)

• 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.

  PMID: 26140672 BACKGROUND

• 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.

  PMID: 29244974 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Andima Basterretxea, MD

  Hospital Universitario de Cruces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 10, 2022
• Study Start: February 5, 2018
• Primary Completion: March 17, 2020
• Study Completion: June 6, 2020
• Last Updated: February 29, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)