Homeless PersonsWARMNCT07640672
The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg.
A study testing Wound care at the University Hospital and in the Johanniter mobile wound care unit in people with Homeless Persons and Wound and Injuries, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homeless Persons, Wound and Injuries, Chronic Wound Care
- What is being tested?
- Wound care at the University Hospital and in the Johanniter mobile wound care unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 over 18
- Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians
- Inclusion of patients who present for wound treatment at the Johanniter-Hilfsmobil, the wound consultation hour of the Clinic for Vascular Surgery at Augsburg University Hospital and/or the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital
- Written consent to participate in the study has been obtained from the test subject.
Who cannot join
- Minderjährigkeit
- Fehlende schriftliche Einwilligung zur Studienteilnahme
- Instabiler somatischer Zustand der Betroffenen
- Akute Selbst- und Fremdgefährdung
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Augsburg
Augsburg, Bavaria, 86156
Tobias D Warm, Dr. med., +498214002655, tobias.warm@uk-augsburg.de
Alexander Hyhlik-Dürr, Prof. Dr. med., +498214002655, alexander.hyhlik-duerr@uk-augsburg.de
About this study
Official title: Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg
Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study.
The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital.
Read more
In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.
Read the detailed description
The primary endpoint is to identify positive and negative influences of environmental factors on the development, progression, and healing of somatic and psychiatric illnesses in homeless people in Augsburg. The answers to the resulting research questions listed below should contribute to the development of a sustainable diagnosis and therapy system by the Johanniter-Hilfsmobil for people in housing emergencies without access to the regular health care system in Augsburg, optimizing addiction treatment for homeless people in the region, and establishing a prevention program for people experiencing housing emergencies in Augsburg, thereby positively influencing the environmental factors described. The long-term plan is to set up a wound and vascular consultation service for people experiencing housing emergencies to improve medical treatment and reintegration into the regular healthcare system.
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonization by taking swabs from the wound bed and performing corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed, and causal therapeutic measures taken to date, as well as the number and regularity of check-ups performed, will be recorded. Furthermore, the influence of environmental factors (including temperature, light, radiation), comorbidities, and nutritional status on wound healing and the effects of dressing sets provided as part of the study on the healing process of the wounds will be analyzed. Data collection will be carried out on an outpatient basis during treatment in the Johanniter-Hilfsmobil. In addition, the existing cardiovascular risk factors will be assessed and a vascular step-by-step diagnosis will be performed, including pulse status assessment and, in the event of pathological findings, non-invasive vascular imaging using ankle-brachial index determination and color-coded duplex sonography (FKDS).
In addition, semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted among drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardized questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, garbage/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. The questionnaire integrates the following measurement instruments/scales, among others: "Life Situation Index for Homeless People", "RTLS - Rasch-Type Loneliness Scale".
However, since this is a very specific target group that has been largely neglected in scientific analysis, the questionnaire also requires some self-formulated items that are appropriate for the research project.
In a final step, a qualitative analysis will be conducted through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.
- Conditions
- Homeless Persons, Wound and Injuries, Chronic Wound Care, Homelessness, Environmental Health, Environmental Factors
- Being tested
- Wound care at the University Hospital and in the Johanniter mobile wound care unit
- Keywords
- wound care, environmental health, wound and injuries, homeless persons, psychiatric disorders, drug abuse/dependence
- Medical subject headings
- Wounds and Injuries, Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound care at the University Hospital and in the Johanniter mobile wound care unitOther
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital.
The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. The influence of environmental factors, comorbidities and nutritional status on wound healing and the effects of the dressing sets provided as part of the study on the healing process of the wounds will also be analysed.
| Study group | Role | What they receive |
|---|---|---|
| Saliva testing | No intervention | Semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted on drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital. |
| Wound Care Treatment | Experimental | A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those in patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital.
The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. Furthermore, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. Receives: Other: Wound care at the University Hospital and in the Johanniter mobile wound care unit |
| Questionnaire on psychosocial life situation | No intervention | The quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardised questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, rubbish/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. |
| Guided interview on psychosocial circumstances | No intervention | A qualitative analysis will be conducted through guided interviews with up to 15 users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg
To answer the research question, the following data will be collected from study participants via a questionnaire and clinical examination:
- Wound area and volume (wound length in cm, wound width in cm, wound area in cm², wound depth in cm),
- Qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and conducting the corresponding laboratory tests (incubation on culture media)
- Determination of the cause of the wounds (for example caused by cold or heat) through medical history and clinical examination
- Assessment of nutritional status by calculating the body mass index (kg/m²)
- Assessment of existing cardiovascular risk factors (for example hypertension, or tobacco use)
- Vascular assessment, including examination of the pulse status in the lower limbs and if pathological findings are observed non-invasive vascular imaging is performed using the ankle-brachial index and colour-coded duplex sonography
Measured: 0-365 days
Identification of a discrepancy between the substance subjectively perceived to have been consumed and the substance objectively detectable in drug-dependent homeless individuals
In order to identify any discrepancies between the substance the study participant subjectively believes they have consumed and the substance objectively detected, saliva tests are carried out which are chemically analysed in the laboratory for the presence of the following groups of substances:
- Amphetamines and derivatives
- Benzodiazepines
- Cocaine and cocaine metabolites
- Cannabinoids
- Other substances (including ketamine)
- Synthetic cannabinoids
To determine the substance the participant subjectively perceives to have consumed, a questionnaire is administered to assess the participant's current substance use.
Measured: 0 - 365 days
Assessing the impact of environmental factors on the psychosocial circumstances of users of the Johanniter mobile support service.
Quantitative analysis of the psychosocial circumstances of users of the Johanniter-Hilfsmobil due to exceptional environmental influences, using a standardised questionnaire.
The following metrics are to be collected:
- Life circumstances index (material situation, gainful employment, housing, health, safety, participation/social networks)
- Environmental factors and weather conditions (heat/cold, precipitation, wind, air quality, noise, litter/unhygienic conditions)
- Opportunities for a healthy lifestyle (diet, access to drinking water, sleep, recovery)
- Use of public spaces and urban infrastructure (mobility, participation, defensive architecture)
- Experiences of loneliness
- Experiences with and access to the medical and psychosocial care system.
Measured: 0 - 365 days
Survey of the psychosocial circumstances and the environmental factors of which they are exposed of homeless people in Augsburg using the Johanniter-Hilfsmobil
As a final step, a qualitative analysis will be carried out through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings regarding their psychosocial circumstances and the environmental factors to which they are exposed.
The following categories will be covered in the personal interview with the homeless persons:
- General living situation
- Public spaces and urban infrastructure
- Environmental influences and weather conditions
- Health
- Social support
- Medical, psychological and social care
Measured: 0-365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Homeless PersonsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is divided into four different study arms. Up to 100 participants are to be included in each study arm. The study arms are intended to lead to scientific insights in the field of wound treatment, substance use and the psychosocial living conditions of homeless people.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Science Augsburg, Germany, Department of Psychiatry, Psychotherapie and Psychosomatics, Medical Faculty, University of Augsburg, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640672
- Sponsor's protocol ID
- 25-0578
- Acronym
- WARM
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As people in housing emergencies are a particularly vulnerable group requiring protection, in accordance with the positive ethical opinion of the Ethics Committee at the Medical Faculty of Ludwig Maximilian University Munich, there are no plans to make the pseudonymised data available to other study centres for further processing.
Publications
1. Gerull S. Systematische Lebenslagenuntersuchung wohnungsloser Menschen 2018 [Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/246 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-2465. 2. Gerull S. Wohnungslos in unsicheren Zeiten 2022 [1-57]. Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/496 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-4961. 3. Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness:Confirmatory Tests on Survey Data. Research on Aging. 2006;28(5):582-98.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg
- ClinicalTrials.gov ID
- NCT07640672
- Acronym / sponsor ID
- WARM / 25-0578
- Conditions
- Homeless Persons, Wound and Injuries, Chronic Wound Care, Homelessness, Environmental Health, Environmental Factors
- Keywords
- wound care, environmental health, wound and injuries, homeless persons, psychiatric disorders, drug abuse/dependence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- University of Applied Science Augsburg, Germany, Department of Psychiatry, Psychotherapie and Psychosomatics, Medical Faculty, University of Augsburg, Germany
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (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.
Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study.
The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital.
In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.
Detailed description
The primary endpoint is to identify positive and negative influences of environmental factors on the development, progression, and healing of somatic and psychiatric illnesses in homeless people in Augsburg. The answers to the resulting research questions listed below should contribute to the development of a sustainable diagnosis and therapy system by the Johanniter-Hilfsmobil for people in housing emergencies without access to the regular health care system in Augsburg, optimizing addiction treatment for homeless people in the region, and establishing a prevention program for people experiencing housing emergencies in Augsburg, thereby positively influencing the environmental factors described. The long-term plan is to set up a wound and vascular consultation service for people experiencing housing emergencies to improve medical treatment and reintegration into the regular healthcare system.
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonization by taking swabs from the wound bed and performing corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed, and causal therapeutic measures taken to date, as well as the number and regularity of check-ups performed, will be recorded. Furthermore, the influence of environmental factors (including temperature, light, radiation), comorbidities, and nutritional status on wound healing and the effects of dressing sets provided as part of the study on the healing process of the wounds will be analyzed. Data collection will be carried out on an outpatient basis during treatment in the Johanniter-Hilfsmobil. In addition, the existing cardiovascular risk factors will be assessed and a vascular step-by-step diagnosis will be performed, including pulse status assessment and, in the event of pathological findings, non-invasive vascular imaging using ankle-brachial index determination and color-coded duplex sonography (FKDS).
In addition, semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted among drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardized questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, garbage/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. The questionnaire integrates the following measurement instruments/scales, among others: "Life Situation Index for Homeless People", "RTLS - Rasch-Type Loneliness Scale".
However, since this is a very specific target group that has been largely neglected in scientific analysis, the questionnaire also requires some self-formulated items that are appropriate for the research project.
In a final step, a qualitative analysis will be conducted through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is divided into four different study arms. Up to 100 participants are to be included in each study arm. The study arms are intended to lead to scientific insights in the field of wound treatment, substance use and the psychosocial living conditions of homeless people.
| Arm | Type | Receives |
|---|---|---|
| Saliva testing | No intervention | –Semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted on drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital. |
| Wound Care Treatment | Experimental | Other: Wound care at the University Hospital and in the Johanniter mobile wound care unitA comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those in patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. Furthermore, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. |
| Questionnaire on psychosocial life situation | No intervention | –The quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardised questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, rubbish/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. |
| Guided interview on psychosocial circumstances | No intervention | –A qualitative analysis will be conducted through guided interviews with up to 15 users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians
- Inclusion of patients who present for wound treatment at the Johanniter-Hilfsmobil, the wound consultation hour of the Clinic for Vascular Surgery at Augsburg University Hospital and/or the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital
- Written consent to participate in the study has been obtained from the test subject.
Key exclusion criteria (4 listed)
- Minderjährigkeit
- Fehlende schriftliche Einwilligung zur Studienteilnahme
- Instabiler somatischer Zustand der Betroffenen
- Akute Selbst- und Fremdgefährdung
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 |
|---|---|---|
| Wound care at the University Hospital and in the Johanniter mobile wound care unitA comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. The influence of environmental factors, comorbidities and nutritional status on wound healing and the effects of the dressing sets provided as part of the study on the healing process of the wounds will also be analysed. | Other | Wound Care Treatment |
Primary outcome
Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg
Time frame: 0-365 days
To answer the research question, the following data will be collected from study participants via a questionnaire and clinical examination: * Wound area and volume (wound length in cm, wound width in cm, wound area in cm², wound depth in cm), * Qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and conducting the corresponding laboratory tests (incubation on culture media) * Determination of the cause of the wounds (for example caused by cold or heat) through medical history and clinical examination * Assessment of nutritional status by calculating the body mass index (kg/m²) * Assessment of existing cardiovascular risk factors (for example hypertension, or tobacco use) * Vascular assessment, including examination of the pulse status in the lower limbs and if pathological findings are observed non-invasive vascular imaging is performed using the ankle-brachial index and colour-coded duplex sonography
Identification of a discrepancy between the substance subjectively perceived to have been consumed and the substance objectively detectable in drug-dependent homeless individuals
Time frame: 0 - 365 days
In order to identify any discrepancies between the substance the study participant subjectively believes they have consumed and the substance objectively detected, saliva tests are carried out which are chemically analysed in the laboratory for the presence of the following groups of substances: * Amphetamines and derivatives * Benzodiazepines * Cocaine and cocaine metabolites * Cannabinoids * Other substances (including ketamine) * Synthetic cannabinoids To determine the substance the participant subjectively perceives to have consumed, a questionnaire is administered to assess the participant's current substance use.
Assessing the impact of environmental factors on the psychosocial circumstances of users of the Johanniter mobile support service.
Time frame: 0 - 365 days
Quantitative analysis of the psychosocial circumstances of users of the Johanniter-Hilfsmobil due to exceptional environmental influences, using a standardised questionnaire. The following metrics are to be collected: * Life circumstances index (material situation, gainful employment, housing, health, safety, participation/social networks) * Environmental factors and weather conditions (heat/cold, precipitation, wind, air quality, noise, litter/unhygienic conditions) * Opportunities for a healthy lifestyle (diet, access to drinking water, sleep, recovery) * Use of public spaces and urban infrastructure (mobility, participation, defensive architecture) * Experiences of loneliness * Experiences with and access to the medical and psychosocial care system.
Survey of the psychosocial circumstances and the environmental factors of which they are exposed of homeless people in Augsburg using the Johanniter-Hilfsmobil
Time frame: 0-365 days
As a final step, a qualitative analysis will be carried out through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings regarding their psychosocial circumstances and the environmental factors to which they are exposed. The following categories will be covered in the personal interview with the homeless persons: * General living situation * Public spaces and urban infrastructure * Environmental influences and weather conditions * Health * Social support * Medical, psychological and social care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background1. Gerull S. Systematische Lebenslagenuntersuchung wohnungsloser Menschen 2018 [Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/246 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-2465. 2. Gerull S. Wohnungslos in unsicheren Zeiten 2022 [1-57]. Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/496 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-4961. 3. Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness:Confirmatory Tests on Survey Data. Research on Aging. 2006;28(5):582-98.
- Individual participant dataSharing planned: No. As people in housing emergencies are a particularly vulnerable group requiring protection, in accordance with the positive ethical opinion of the Ethics Committee at the Medical Faculty of Ludwig Maximilian University Munich, there are no plans to make the pseudonymised data available to other study centres for further processing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound care at the University Hospital and in the Johanniter mobile wound care unit in people with Homeless Persons and Wound and Injuries, run by University Hospital Augsburg at 1 site in Germany.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg (time frame: 0-365 days). The study lists 4 primary outcomes in all. 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 NCT07640672, which also lists 1 linked publication.
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 11 Jun 2026.