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Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing

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ClinicalTrials.gov Identifier: NCT03985306
Recruitment Status : Active, not recruiting
First Posted : June 13, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

This trial will examine the feasibility of conducting a definitive randomized clinical trial that tests whether inforatio technique will reduce time to healing of diabetic foot ulcers. Inforatio technique is a procedure where small punch biopsies are taken from the wound bed near the edge of the wound. With this technique, the investigators wish to initiate an acute inflammatory response that increases the generation of granulation tissue with subsequent healing by scar formation. Thus, the investigators hypothesize that inforatio technique will promote healing of diabetic foot ulcers.

Based on clinical experience, the investigators have previously detected a reduction in time to healing as an unexpected effect when multiple punch biopsies are taken from the wound bed of diabetic foot ulcers. To the knowledge of the investigators, methods similar to the inforatio technique has not previously been studied.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Foot Wound Heal Ulcer Foot Ulcer Healing Procedure: Inforatio technique Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

The trial is a single-center single-group feasibility trial in outpatient clinical settings.

The trial will be reported with reference to the extended CONSORT guidelines.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: a Feasibility Trial
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feasibility trial group
Every trial patient will receive the intervention (the inforatio technique) that is intended for the definitive randomized clinical trial.
Procedure: Inforatio technique

We define the inforatio technique as punch biopsies taken in the periphery of the wound bed. The punch biopsies will have a diameter of two mms. The depth of the biopsies is primarily based on clinical assessment on distance to bone by assessment with a sterile wound probe and with attention to location and anatomy. The maximum depth will be 3.5 millimeters. The biopsies will be taken from one to two mms from the wound edges and with a distance of five mms between the biopsies.

Inforatio technique is applied after standard care and wound assessment.





Primary Outcome Measures :
  1. Eligibility rates [ Time Frame: The first 2 months of the trial (untill the last patient has been recruited) ]
    Descriptive statistics of number and rate of eligible patients during the period of recruitment

  2. Refusal rates [ Time Frame: The first 2 months of the trial (untill the last patient has been recruited) ]
    Descriptive statistics of number and rate of eligible patients that refuse trial participation.

  3. Time from identification to inclusion [ Time Frame: The first 2 months of the trial (untill the last patient has been recruited) ]
    Descriptive statistics of average time from eligible patients are identified to they are included in the trial (baseline trial visit)

  4. Qualitative assessment of unexpected factors that must cause exclusion [ Time Frame: 10 months ]
    Qualitatively assessed by the primary investigator

  5. Rate of unexpected exclusion [ Time Frame: 10 months ]
    Descriptive statistics of number and rate of patients that are excluded due to reasons not already covered by the trial definition of exclusion criteria.

  6. Retention rates [ Time Frame: 10 months ]
    To investigate protocol adherence, the number and rate of participants that adhere to follow-up will be reported.

  7. Number of missed trial follow-up visits [ Time Frame: 10 months ]
    To investigate protocol adherence, the number of missed trial visits will be reported for each participant.

  8. Drop-out rates [ Time Frame: 10 months ]
    To investigate protocol adherence, the number and rate of participants that choose to drop out during follow-up will be reported.

  9. Rate of eligible patients that accept participation [ Time Frame: At baseline, each follow-up visit and when patients drop out. ]
    A quantitative investigation of patient acceptability.

  10. Qualitative assessment of patient acceptability [ Time Frame: 10 months ]
    Assessed by interviews with participants.

  11. Observed harms and unexpected effects [ Time Frame: 10 months ]
    Observed harms and unexpected effects observed by the investigators and staff will be reported.

  12. Patient-reported potential side effects [ Time Frame: 10 months ]
    A qualitatively assessment of harms and unexpected effects by interviewing participants about potential side effects that they experience.

  13. Qualitative assessment of logistics issues regarding outpatient clinic visits [ Time Frame: 10 months ]
    The investigators qualitatively assesses logistic circumstances that may be optimized.The assessment includes whether dates of follow-up visits fit the routines at the outpatient clinics.

  14. Time to healing of punch biopsy scars [ Time Frame: 10 months ]
    The time to healing will be reported to estimate if and when observer blinding may be possible.

  15. Qualitative assessment of the method of wound assessment. [ Time Frame: 10 months ]
    The investigators assess complications related to the method wound bed area and the depth. The aim is to optimize wound assessment for the future definitive trial.

  16. Qualitative assessment of the extent of qualitative patient measures [ Time Frame: 10 months ]
    The investigators assess whether the qualitative patient measures are either too extensive or insufficient. Thus, estimating necessary changes to make the qualitative measurements feasible to include in the future definitive trial.

  17. Qualitative assessment of the feasibility of culturing 3 biopsies from each round of inforatio technique applications for a future definitive trial. [ Time Frame: 10 months ]
    The investigators assess whether the included centers have the capacity to culture three biopsies two times from each patient.

  18. Rates of wound treatments at trial visits that deviate from the trial standard treatment definition [ Time Frame: 10 months ]
    Standard treatments received by each patient at the follow-up visits are recorded and it is assessed whether the standard care received corresponds to the definition of the trial standard treatment.

  19. Qualitative assessment of wound care treatments received between trial visits and the deviations from the trial definition of standard treatment. [ Time Frame: 10 months ]
    The investigators assess the heterogeneity of treatment during follow-up by recording the number of hospital visits between the trial follow-up visits and the treatments and assessments received at these hospital visits.

  20. Time to healing of the foot ulcers [ Time Frame: 10 months ]
    The investigators will report mean and variance of time to healing

  21. Patient-reported experience of trial participation and the inforatio technique [ Time Frame: 10 months ]
    The investigators will interview the patient about their experience of trial participation and of the inforatio technique.

  22. Staff acceptability [ Time Frame: 10 months ]
    Assessed qualitatively by interviews with the staff at the outpatient clinics (wound care nurses and podiatrists)

  23. Qualitative assessment of the inforatio technique [ Time Frame: 5 months. At baseline application and at the 21-day applications. ]
    The method of inforatio technique application will be qualitatively assessed by the applicant. The applicant will report any issues or complications regarding the inforatio technique definition.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

We include diabetic patients with foot ulcers that are more than six weeks old and which are located distal to the malleoli.

The diameters of the ulcers must be at least four mms. One wound from each foot of a patient can be included. If a patient's foot have more than one ulcer that meets the abovementioned criteria, the biggest wound is included. If there is no difference in size, the wound that has the most recent onset is included. If two wounds are close to each other and separated by less than 5 mm intact skin, we will consider it as one wound.

Wound onset estimates will be patient-reported.

EXCLUSION CRITERIA:

We exclude following patients:

  • Patients with dementia and other patients who are not able to give their informed consent.
  • Patients with gangrene, necrosis deeper than 1mm, osteomyelitis and clinical signs of infection in their foot. Infection is identified by clinical assessment based on the classical signs comprising oedema, pain, warmth, redness and purulent exudates and is assessed by an experienced orthopedic surgeon.
  • Patients with ulcers that have positive probe-to-bone test and visible joint and tendons
  • Patients with systolic toe pressure of < 20 mmHg
  • Patients that, since the onset of their present foot ulcer, underwent vascular surgery in the lower extremity with the same laterality as the foot ulcer.
  • Patients that, since the onset of their present foot ulcer, underwent surgical off-loading and amputations
  • Patients that, since the onset of their present foot ulcer, underwent surgical wound revisions in an operating room.
  • Patients that have an acute phase of Charcot arthropathy in the foot that presents with a foot ulcer.
  • Patients that take systemic immunosuppressive drugs.
  • Patients with cancer
  • Patients with scleroderma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985306


Locations
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Denmark
Herlev University Hospital, Department of Orthopaedic Surgery
Herlev, Denmark, 2730
Zealand University Hospital, Department of Orthopaedic Surgery
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Sahar Moeini, MD Zealand University Hospital Koege, Denmark
Study Chair: Hans Gottlieb, Chief consultant, MD PhD Herlev University Hospital, Denmark
Study Chair: Tue S Jørgensen, MD PhD Hvidovre University Hospital, Denmark
Study Chair: Malene RB Larsen, MD Zealand University Hospital Koege, Denmark
Principal Investigator: Stig Brorson, Professor, MD PhD DMsc Zealand University Hospital Koege, Denmark

Publications:
SIGN. 116 Management of diabetes. A national clinical guideline. 2017; Available from: https://www.sign.ac.uk/assets/sign116.pdf
NICE Guideline. Diabetic foot problems: prevention and management [Internet]. [cited 2019 Jan 3]. Available from: https://www.nice.org.uk/guidance/ng19
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat [Internet]. 2005;4(4):287-91. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/pst.185

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03985306     History of Changes
Other Study ID Numbers: REG-122-2018
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zealand University Hospital:
Diabetic foot ulcer
Wound treatment
Inforatio technique
Diabetes
Foot ulcer
Outpatient clinic
Feasibility trial
Punch biopsy
Foot ulcer treatment

Additional relevant MeSH terms:
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Wounds and Injuries
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases