Diabetic Foot UlcerNCT05189470
Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers
A study testing Inforatio technique in people with Diabetic Foot Ulcer and Diabetes, run by Zealand University Hospital at 4 sites in Denmark.
Trial summary
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs). Inforatio technique is a novel procedure developed by the research group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes, Foot Ulcer
- What is being tested?
- Inforatio technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesDenmark
- Study dates
- 10 Mar 2022to 14 Aug 2025
- 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
- Age ≥ 18 years
- Diabetes mellitus
- Non-surgical ulcer located distal to the malleoli
- Wound diameter >4 millimeters
- Patient-reported wound duration ≥ 6 weeks
- Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included.
Who cannot join
- Dementia or other reasons that cause inability to give informed consent
- Malignant disease
- Current treatment with systemic immunosuppressive drugs.
- Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
- Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure <30 mmHg in the index foot.
- Amputation at midfoot level or proximal to midfoot level
Show all 13Show fewer
- Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization
- Gangrene
- Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema >0.5 to ≤2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection.
- Positive probe-to-bone test
- Exposed joint or tendon
- The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed.
- Interdigital ulcer location
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Herlev University Hospital, Department of Orthopaedic Surgery
Herlev, 2730
Zealand University Hospital, Department of Orthopaedic Surgery
Køge, 4600
Nykoebing Falster Hospital
Nykøbing Falster, 4800
Slagelse Hospital, Department of Orthopaedic Surgery
Slagelse, 4200
About this study
Official title: Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).
Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.
Read the detailed description
BACKGROUND
15-25% of diabetic patients develop chronic foot ulcers - a serious comorbidity that widely affects quality of life and is associated with increased mortality and morbidity. 50-60% of DFUs become infected, and 20% of patients with infected DFUs undergo lower extremity amputation.
Inforatio technique is a novel treatment of DFUs where small cuts are made in wound beds with punch biopsy tools without involving epithelia. The aim is to cause controlled bleeding and initiate an acute inflammatory response that may promote healing.
The research group has conducted a preceding feasibility trial that showed promising results (see study by Moeini et al. in the reference list). Inforatio technique may become a supplemental treatment option for diabetic patients worldwide if it shows a beneficial effect on healing.
TRIAL AIMS
This trial aims to assess whether the proportion of ulcers that heal within 20 weeks is higher when DFUs are treated with inforatio technique in addition to usual wound care compared to treatment with usual wound care alone.
RECRUITMENT
Patients are eligibility-screened and identified by the investigators and wound care staff when patients visit the recruiting wound outpatient clinics.
INCLUSION AND FOLLOW-UP
Eligible patients are included if they give their oral and written consent to participate. The baseline trial visit takes place on the day that patients give their consent to participate.
The trial comprises a 20-week clinical follow-up. Follow-up visits will be at 3, 6, 9, 12, 16 and 20 weeks after baseline (give or take 7 days for midtrial visits and from 20 to 22 weeks after baseline for the last trial visit).
Follow-up end whenever the following appears; 20-week follow-up visit, death, amputation, or the outpatient clinic staff observes healing.
The trial will be stopped if the intervention shows an unintended effect or potential harm.
RANDOMIZATION
Allocation of participants is conducted by block randomization with stratification by center and will be generated with Research Electronic Data Capture (REDCap)©. Block sizes will be randomly alternating between two and four. The allocation will immediately be revealed to the participant and wound care staff. Adequate allocation concealment is ensured by the irreversibility of randomization and the inability to predict the next allocation assignment in RedCap.
STATISTICAL ANALYSIS PLAN
Baseline characteristics will be reported with appropriate descriptive statistics. The analyses of primary and secondary outcomes will be performed on the intention-to-treat population with participants being analyzed as randomized regardless of the treatment received. Supplementary analyses will be performed on the per-protocol population, which excludes participants with one or more serious protocol violations as defined below:
- Participants not receiving their allocated treatment.
- Participants with inadequate adherence, which is defined as the following:
- Participants that miss more than 3 of the 6 follow-up trial visits.
- Participants in the intervention group that miss more than 2 of the 4 trial visits where inforatio is applied.
The primary analysis of the trial will be a logistic regression for proportion of healed ulcers with adjustment for center of recruitment.
EQ-5D-5L and Wound-QoL data will be presented descriptively in line with the guidelines for the questionnaires. A multivariate linear regression adjusting for baseline score will be performed for analysis of change in EQ-5D-5L index score and Wound-QoL global score.
Safety outcome will be descriptively reported and analyzed on 'as treated' basis where participants are grouped according to whether they received inforatio technique. Mean time and range from the last inforatio applied to an event is detected will be reported for the intervention group. A statistical comparison between groups will be conducted by chi square test and estimates of relative risk with 95% confidence interval. Inforatio-related adverse events will be descriptively reported.
An interim analyses will be performed after 50 participant has completed follow-up.
Significance is set at p-value <0.05 and p-values are two-tailed. Underlying statistical assumptions for linear and logistic regressions will be assessed graphically.
HANDLING OF MISSING DATA
Data on Wound-QoL global score that is missing due to death during follow-up, will not be considered in the handling of missing data. Otherwise, missing data on primary and secondary outcomes will be handled according to recommendations by Jakobsen et al. (see reference list). If the proportion of missing data on an outcome is <5%, the primary analysis of missing data will be complete-case analyses. If more than 5% data of an outcome is missing, the primary analysis will include missing data imputed by multiple imputation technique and complete case analysis will be performed as a sensitivity analysis. In both cases, a best-worst and worst-best case analysis will be conducted for missing data on healing.
SAMPLE SIZE
A meta analysis by Margolis et al. (see reference list) has reported a healing rate of 30.9% (95% CI 26.6-35.1) in 20 weeks for non-infected DFUs that were treated with standard wound care. A healing rate of 60% in 20 weeks was suggested by the preceding feasibility trial when patients receive inforatio technique in addition to usual wound care.
When the power is 80% and the alpha-level is 5%, a power calculation gives a sample size of 84 for comparison of two proportions when the outcome proportion is 30% for the control group and the aim is to assess whether the outcome improves with 30 percentage points in the intervention group. To allow an attrition of 20%, the aim is to recruit 100 participants for the trial.
ETHICAL CONSIDERATIONS AND RISK ASSESSMENT OF SIDE EFFECTS
Inforatio technique is a minimal invasive procedure. Thus, no adverse events are expected as a result of inforatio technique except from a low risk of pain during application. In the preceding feasibility trial, no intervention-related adverse events were observed and participants did not experience pain during application. Furthermore, inforatio technique showed a promising effect on healing.
The clinical assessment of the wound care staff, patient preference and patient tolerance is taken into consideration before inforatio technique is applied.
If the inforatio technique shows a significant positive effect on healing, it would become of great importance for future patients as a supplemental treatment to standard wound care of DFUs.
COMPETING INTERESTS
The trial investigators declare that they have no competing interests.
- Conditions
- Diabetic Foot Ulcer, Diabetes, Foot Ulcer, Diabetic Foot, Diabetes Complications, Diabetes Mellitus
- Being tested
- Inforatio technique, Usual care of the respective outpatient clinics
- Keywords
- Diabetic Foot Ulcer, Wound treatment, Inforatio technique
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inforatio techniqueProcedure or surgery
Inforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools near the wound edges but without involving wound edge epithelia. Inforatio technique is applied after the wound has been surgically debrided for slough and devitalized tissue.
Usual care of the respective outpatient clinicsOther
Usual care of the DFUs includes local wound care and offloading treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | These participants will receive the usual care of the respective outpatient clinics. Receives: Other: Usual care of the respective outpatient clinics |
| Intervention group | Experimental | Participants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer. Receives: Procedure: Inforatio technique; Other: Usual care of the respective outpatient clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing
Healing is defined as complete epithelialization without any discharge from the site of the index ulcer.
The primary outcome is the proportion of ulcers in each allocation group where healing is observed based on blinded assessment of digital images from the participants' last trial visit. The assessment of healing on digital images will be performed separately by two blinded assessors. Digital images where disagreement occurs are discussed between the assessors until agreement is reached. Any inconsistencies between the blinded assessment of healing on images and unblinded clinical assessment at trial visits will be reported.
In case of death and amputation the primary outcome is registered as non-healing.
Measured: 20 weeks
Secondary outcomes (2)
Change in EQ-5D-5L visual analog scale (EQ VAS) score from baseline to end of follow-up
The EQ VAS score is used to assess change in participant-rated health from baseline to end of follow-up.
Participants fill out the Danish version of the EQ-5D-5L questionnaire at baseline and the last trial visit or after 20 weeks from the day of amputation if participants undergo amputation of their index limb during follow-up. EQ-5D-5L is a general health patient-reported outcome measure that includes a visual analog scale and a descriptive 5-dimension system. Permission to use EQ5-5D-5L (registration ID 39403) has been obtained.
In case of death, the EQ VAS score will be registered as missing.
Measured: 20 weeks
Change in Wound-QoL global score from baseline to end of follow-up
Wound-QoL global score is used to assess change in disease-specific quality of life from baseline to end of follow-up.
Participants fill out the Danish version of the Wound-QoL questionnaire at baseline and the last trial visit. The Wound-QoL is a disease-specific patient-reported outcome measure that consists of 17 items, which each has a score from 0 to 4 - 0 indicates no problem and 4 is the highest score for an ulcer-related problem. The global Wound-QoL score is an average of all item scores. In case of death, the Wound-Qol score will be registered as missing. In case of amputation of the index extremity, the Wound-QoL global score is 4, which represents the worst possible outcome for Wound-QoL. The Wound-QoL response is defined as missing if less than 13 of the 17 items have been completed. Permission to the Danish version of the Wound-QoL has been obtained.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Mar 2022
- Primary completion18 Dec 2024
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Sjaelland
- Responsible party
- Sponsor
- Investigators
- Sahar Moeini, MD, Principal investigator, Zealand University HospitalHans Gottlieb, MD PhD, Study chair, University of CopenhagenTue S Jørgensen, MD PhD, Study chair, Zealand University HospitalThomas V Aagaard, PT MsC, Study chair, Holbaek HospitalMaj R Kornø, MD, Study chair, Nykoebing Falster HospitalMalene RB Larsen, MD, Study chair, Zealand University HospitalStig Brorson, MD PhD DMsc, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189470
- Sponsor's protocol ID
- EMN-2021-08362
- Other IDs
- SJ-904, REG-116-2021
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrews KL, Houdek MT, Kiemele LJ. Wound management of chronic diabetic foot ulcers: from the basics to regenerative medicine. Prosthet Orthot Int. 2015 Feb;39(1):29-39. doi: 10.1177/0309364614534296.
PubMed 25614499Karri VV, Kuppusamy G, Talluri SV, Yamjala K, Mannemala SS, Malayandi R. Current and emerging therapies in the management of diabetic foot ulcers. Curr Med Res Opin. 2016;32(3):519-42. doi: 10.1185/03007995.2015.1128888. Epub 2016 Jan 12.
PubMed 26643047Zimny S, Pfohl M. Healing times and prediction of wound healing in neuropathic diabetic foot ulcers: a prospective study. Exp Clin Endocrinol Diabetes. 2005 Feb;113(2):90-3. doi: 10.1055/s-2004-830537.
PubMed 15772900Greer N, Foman NA, MacDonald R, Dorrian J, Fitzgerald P, Rutks I, Wilt TJ. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Ann Intern Med. 2013 Oct 15;159(8):532-42. doi: 10.7326/0003-4819-159-8-201310150-00006.
PubMed 24126647Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/
PubMed 33347096Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.
PubMed 29207961Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692.
PubMed 10332667Moeini S, Gottlieb H, Jorgensen TS, Larsen MRB, Brorson S. Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: A Feasibility Trial. Int J Low Extrem Wounds. 2023 Jun;22(2):241-250. doi: 10.1177/15347346211002364. Epub 2021 Apr 28.
PubMed 33909504Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.
PubMed 32176445Moeini S, Gottlieb H, Jorgensen TS, Aagaard TV, Korno MR, Larsen MRB, Brorson S. Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial. BMJ Open. 2022 Sep 19;12(9):e062344. doi: 10.1136/bmjopen-2022-062344.
PubMed 36123051
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05189470
- Acronym / sponsor ID
- EMN-2021-08362
- Conditions
- Diabetic Foot Ulcer, Diabetes, Foot Ulcer, Diabetic Foot, Diabetes Complications, Diabetes Mellitus
- Keywords
- Diabetic Foot Ulcer, Wound treatment, Inforatio technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Sjaelland
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 12 Jan 2022 (actual)
- 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.
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).
Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.
Detailed description
BACKGROUND
15-25% of diabetic patients develop chronic foot ulcers - a serious comorbidity that widely affects quality of life and is associated with increased mortality and morbidity. 50-60% of DFUs become infected, and 20% of patients with infected DFUs undergo lower extremity amputation.
Inforatio technique is a novel treatment of DFUs where small cuts are made in wound beds with punch biopsy tools without involving epithelia. The aim is to cause controlled bleeding and initiate an acute inflammatory response that may promote healing.
The research group has conducted a preceding feasibility trial that showed promising results (see study by Moeini et al. in the reference list). Inforatio technique may become a supplemental treatment option for diabetic patients worldwide if it shows a beneficial effect on healing.
TRIAL AIMS
This trial aims to assess whether the proportion of ulcers that heal within 20 weeks is higher when DFUs are treated with inforatio technique in addition to usual wound care compared to treatment with usual wound care alone.
RECRUITMENT
Patients are eligibility-screened and identified by the investigators and wound care staff when patients visit the recruiting wound outpatient clinics.
INCLUSION AND FOLLOW-UP
Eligible patients are included if they give their oral and written consent to participate. The baseline trial visit takes place on the day that patients give their consent to participate.
The trial comprises a 20-week clinical follow-up. Follow-up visits will be at 3, 6, 9, 12, 16 and 20 weeks after baseline (give or take 7 days for midtrial visits and from 20 to 22 weeks after baseline for the last trial visit).
Follow-up end whenever the following appears; 20-week follow-up visit, death, amputation, or the outpatient clinic staff observes healing.
The trial will be stopped if the intervention shows an unintended effect or potential harm.
RANDOMIZATION
Allocation of participants is conducted by block randomization with stratification by center and will be generated with Research Electronic Data Capture (REDCap)©. Block sizes will be randomly alternating between two and four. The allocation will immediately be revealed to the participant and wound care staff. Adequate allocation concealment is ensured by the irreversibility of randomization and the inability to predict the next allocation assignment in RedCap.
STATISTICAL ANALYSIS PLAN
Baseline characteristics will be reported with appropriate descriptive statistics. The analyses of primary and secondary outcomes will be performed on the intention-to-treat population with participants being analyzed as randomized regardless of the treatment received. Supplementary analyses will be performed on the per-protocol population, which excludes participants with one or more serious protocol violations as defined below:
- Participants not receiving their allocated treatment.
- Participants with inadequate adherence, which is defined as the following:
- Participants that miss more than 3 of the 6 follow-up trial visits.
- Participants in the intervention group that miss more than 2 of the 4 trial visits where inforatio is applied.
The primary analysis of the trial will be a logistic regression for proportion of healed ulcers with adjustment for center of recruitment.
EQ-5D-5L and Wound-QoL data will be presented descriptively in line with the guidelines for the questionnaires. A multivariate linear regression adjusting for baseline score will be performed for analysis of change in EQ-5D-5L index score and Wound-QoL global score.
Safety outcome will be descriptively reported and analyzed on 'as treated' basis where participants are grouped according to whether they received inforatio technique. Mean time and range from the last inforatio applied to an event is detected will be reported for the intervention group. A statistical comparison between groups will be conducted by chi square test and estimates of relative risk with 95% confidence interval. Inforatio-related adverse events will be descriptively reported.
An interim analyses will be performed after 50 participant has completed follow-up.
Significance is set at p-value <0.05 and p-values are two-tailed. Underlying statistical assumptions for linear and logistic regressions will be assessed graphically.
HANDLING OF MISSING DATA
Data on Wound-QoL global score that is missing due to death during follow-up, will not be considered in the handling of missing data. Otherwise, missing data on primary and secondary outcomes will be handled according to recommendations by Jakobsen et al. (see reference list). If the proportion of missing data on an outcome is <5%, the primary analysis of missing data will be complete-case analyses. If more than 5% data of an outcome is missing, the primary analysis will include missing data imputed by multiple imputation technique and complete case analysis will be performed as a sensitivity analysis. In both cases, a best-worst and worst-best case analysis will be conducted for missing data on healing.
SAMPLE SIZE
A meta analysis by Margolis et al. (see reference list) has reported a healing rate of 30.9% (95% CI 26.6-35.1) in 20 weeks for non-infected DFUs that were treated with standard wound care. A healing rate of 60% in 20 weeks was suggested by the preceding feasibility trial when patients receive inforatio technique in addition to usual wound care.
When the power is 80% and the alpha-level is 5%, a power calculation gives a sample size of 84 for comparison of two proportions when the outcome proportion is 30% for the control group and the aim is to assess whether the outcome improves with 30 percentage points in the intervention group. To allow an attrition of 20%, the aim is to recruit 100 participants for the trial.
ETHICAL CONSIDERATIONS AND RISK ASSESSMENT OF SIDE EFFECTS
Inforatio technique is a minimal invasive procedure. Thus, no adverse events are expected as a result of inforatio technique except from a low risk of pain during application. In the preceding feasibility trial, no intervention-related adverse events were observed and participants did not experience pain during application. Furthermore, inforatio technique showed a promising effect on healing.
The clinical assessment of the wound care staff, patient preference and patient tolerance is taken into consideration before inforatio technique is applied.
If the inforatio technique shows a significant positive effect on healing, it would become of great importance for future patients as a supplemental treatment to standard wound care of DFUs.
COMPETING INTERESTS
The trial investigators declare that they have no competing interests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Usual care of the respective outpatient clinicsThese participants will receive the usual care of the respective outpatient clinics. |
| Intervention group | Experimental | Procedure: Inforatio technique, Other: Usual care of the respective outpatient clinicsParticipants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diabetes mellitus
- Non-surgical ulcer located distal to the malleoli
- Wound diameter >4 millimeters
- Patient-reported wound duration ≥ 6 weeks
Key exclusion criteria (13 listed)
- Dementia or other reasons that cause inability to give informed consent
- Malignant disease
- Current treatment with systemic immunosuppressive drugs.
- Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
- Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure <30 mmHg in the index foot.
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 |
|---|---|---|
| Inforatio techniqueInforatio technique is a novel minimal invasive procedure where small cuts are made on wound beds with punch biopsy tools near the wound edges but without involving wound edge epithelia. Inforatio technique is applied after the wound has been surgically debrided for slough and devitalized tissue. | Procedure or surgery | Intervention group |
| Usual care of the respective outpatient clinicsUsual care of the DFUs includes local wound care and offloading treatment. | Other | Control group, Intervention group |
Primary outcome
Complete healing
Time frame: 20 weeks
Healing is defined as complete epithelialization without any discharge from the site of the index ulcer. The primary outcome is the proportion of ulcers in each allocation group where healing is observed based on blinded assessment of digital images from the participants' last trial visit. The assessment of healing on digital images will be performed separately by two blinded assessors. Digital images where disagreement occurs are discussed between the assessors until agreement is reached. Any inconsistencies between the blinded assessment of healing on images and unblinded clinical assessment at trial visits will be reported. In case of death and amputation the primary outcome is registered as non-healing.
2 secondary outcomes
Change in EQ-5D-5L visual analog scale (EQ VAS) score from baseline to end of follow-up
Time frame: 20 weeks
Change in Wound-QoL global score from baseline to end of follow-up
Time frame: 20 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 25 Mar 2026.
- Background: PubMed 25614499Andrews KL, Houdek MT, Kiemele LJ. Wound management of chronic diabetic foot ulcers: from the basics to regenerative medicine. Prosthet Orthot Int. 2015 Feb;39(1):29-39. doi: 10.1177/0309364614534296.
- Background: PubMed 26643047Karri VV, Kuppusamy G, Talluri SV, Yamjala K, Mannemala SS, Malayandi R. Current and emerging therapies in the management of diabetic foot ulcers. Curr Med Res Opin. 2016;32(3):519-42. doi: 10.1185/03007995.2015.1128888. Epub 2016 Jan 12.
- Background: PubMed 15772900Zimny S, Pfohl M. Healing times and prediction of wound healing in neuropathic diabetic foot ulcers: a prospective study. Exp Clin Endocrinol Diabetes. 2005 Feb;113(2):90-3. doi: 10.1055/s-2004-830537.
- Background: PubMed 24126647Greer N, Foman NA, MacDonald R, Dorrian J, Fitzgerald P, Rutks I, Wilt TJ. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Ann Intern Med. 2013 Oct 15;159(8):532-42. doi: 10.7326/0003-4819-159-8-201310150-00006.
- Background: PubMed 33347096Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/
- Background: PubMed 29207961Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.
- Background: PubMed 10332667Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692.
- Background: PubMed 33909504Moeini S, Gottlieb H, Jorgensen TS, Larsen MRB, Brorson S. Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: A Feasibility Trial. Int J Low Extrem Wounds. 2023 Jun;22(2):241-250. doi: 10.1177/15347346211002364. Epub 2021 Apr 28.
- Background: PubMed 32176445Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.
- Derived from this study: PubMed 36123051Moeini S, Gottlieb H, Jorgensen TS, Aagaard TV, Korno MR, Larsen MRB, Brorson S. Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial. BMJ Open. 2022 Sep 19;12(9):e062344. doi: 10.1136/bmjopen-2022-062344.
- Chadwick P, Edmonds M, Mccardle J, Armstrong D. International Best Practice Guidelines: Wound management in diabetic foot ulcers. Wounds International. Published 2013. Accessed November 26, 2020.Link provided by the sponsor.
- EuroQol Research Foundation. EQ-5D-5L User Guide. Published 2019. Accessed December 16, 2020.Link provided by the sponsor.
- FDA. What is a Serious Adverse Event? Published 2016. Accessed December 16, 2020.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sahar Moeini, MD principal investigator
Zealand University Hospital
Hans Gottlieb, MD PhD study chair
University of Copenhagen
Tue S Jørgensen, MD PhD study chair
Zealand University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inforatio technique in people with Diabetic Foot Ulcer and Diabetes, run by Zealand University Hospital at 4 sites in Denmark.
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 6 inclusion and 13 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
Complete healing (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189470, which also lists 10 linked publications.
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 25 Mar 2026.