Diabetic Foot Ulcer (DFU)NCT01912092
Askina Calgitrol Paste Diabetic Foot Ulcers
A study testing Askina Calgitrol paste in people with Diabetic Foot Ulcer (DFU), run by BBraun Medical SAS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Askina Calgitrol paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
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- Transcutaneous oxygen pressure (TcPO2) > 30 mmHg.
- Toe pressure > 50 mmHg.
- Ankle pressure > 70 mmHg.
- Capable of following Study instructions.
- Compliant with treatment and in particular with off-loading regime.
- Stable management of their diabetes as defined by an HbA1C (%) of 12%
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Diabetic Foot and metabolic diseases clinic
Milan
IRCCS Casa di Cura MultiMedica
Milan
About this study
Official title: A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS
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.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Askina Calgitrol paste
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Askina Calgitrol pasteDevice
| Study group | Role | What they receive |
|---|---|---|
| Askina Calgitrol Paste | Experimental | Not described Receives: Device: Askina Calgitrol paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)
During each of the day 2 and weekly control visits, the investigator will observe the wound visually and assess it for signs of Clinical infection, using the Guidelines for Diabetic Foot Ulcer infection of the Infectious Diseases Society of America. The investigator will score the degree of infection of the wound according to a table adapted from the 8 items wound score for diabetic foot infections.
In general, treatment with Askina Calgitrol Paste will be discontinued when local infection has resolved or when it was worsened since the last control visit. However, treatment of Askina Calgitrol Paste will continued after 4 weeks of treatment only if there are signs of improvement.
The treatment period of Askina Calgitrol Paste will last a maximum of 6 weeks.
Measured: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Secondary outcomes (4)
Adverse events or Adverse device related event
Measured: At day 2 and weekly in a period of a maximum of 6 weeks
Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)
It will be assessed visually by the investigator.
Measured: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Ease of use of Askina Calgitrol Paste
Ease of application and removal of dressing will be assessed by the subject/subject's relatives and the investigator using a rating scale of 1 (very easy) to 5 (very difficult). Dressing change at home will be evaluated in a patient diary by the patient or the carer and dressing changes in the clinic by the investigator.
Measured: Daily or at every change of dressing, in a period of a maximum of 6 weeks
Wound surface area
It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional.
Measured: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912092
- Sponsor's protocol ID
- OPM-O-H-1205
- Status last verified
- Jul 2015
- First submitted
- 25 Jul 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS
- ClinicalTrials.gov ID
- NCT01912092
- Acronym / sponsor ID
- OPM-O-H-1205
- Conditions
- Diabetic Foot Ulcer (DFU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Askina Calgitrol Paste | Experimental | Device: Askina Calgitrol paste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Askina Calgitrol paste | Device | Askina Calgitrol Paste |
Primary outcome
Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)
Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
During each of the day 2 and weekly control visits, the investigator will observe the wound visually and assess it for signs of Clinical infection, using the Guidelines for Diabetic Foot Ulcer infection of the Infectious Diseases Society of America. The investigator will score the degree of infection of the wound according to a table adapted from the 8 items wound score for diabetic foot infections. In general, treatment with Askina Calgitrol Paste will be discontinued when local infection has resolved or when it was worsened since the last control visit. However, treatment of Askina Calgitrol Paste will continued after 4 weeks of treatment only if there are signs of improvement. The treatment period of Askina Calgitrol Paste will last a maximum of 6 weeks.
4 secondary outcomes
Adverse events or Adverse device related event
Time frame: At day 2 and weekly in a period of a maximum of 6 weeks
Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)
Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Ease of use of Askina Calgitrol Paste
Time frame: Daily or at every change of dressing, in a period of a maximum of 6 weeks
Wound surface area
Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Askina Calgitrol paste in people with Diabetic Foot Ulcer (DFU), run by BBraun Medical SAS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration) (time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015; AzTrials last refreshed its copy on 26 Oct 2026.