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Askina Calgitrol Paste Diabetic Foot Ulcers | Clinical Trials | Clareo Health

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Askina Calgitrol Paste Diabetic Foot Ulcers

A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS

NCT01912092•BBraun Medical SAS

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject older than 18 years old
•Provision of written consent by the subject themselves
•Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
•Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
•Size of wound \>2 cm2.
•Absence of ischaemia of the lower limb as assessed by :
•1. Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
•2. Toe pressure \> 50 mmHg.
•3. Ankle pressure \> 70 mmHg.
•Capable of following Study instructions.
+2 more criteria

Exclusion Criteria

•Subjects who are \<18 years old.
•Subjects with a documented sensitivity to alginates or silver.
•Subjects taking a medication or using a device comprising silver.
•Subjects already taking antibiotics before enrolment
•Subjects undergoing dialysis.
•Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
•Pregnancy
•Breast-feeding
•Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study

Locations (2)

Diabetic Foot and metabolic diseases clinic

Milan, Italy

IRCCS Casa di Cura MultiMedica

Milan, Italy

Key Dates

Start Date

April 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

July 31, 2015

Enrollment

ACTUAL participants

Conditions

Diabetic Foot Ulcer (DFU)

Interventions

Askina Calgitrol paste

DEVICE

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

NCT07116876

Diabetic Foot Ulcer (DFU)Lower Extremity

View study

RECRUITINGPHASE4

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

NCT07086443

Diabetic Foot UlcerDFU+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Askina Calgitrol Paste Diabetic Foot Ulcers

Inclusion Criteria

Exclusion Criteria

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

AI Wound Alert & Home Management for Recurrent DFU

Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers

Exploring the Effect of Fespixon Cream for the Treatment of Diabetic Foot Ulcers (TEXAS 3A, 3B)