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.

Condition(s) studied

Investigational drug(s) / intervention(s)

Wound care at the University Hospital and in the Johanniter mobile wound care unit: 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 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 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.

Eligibility

Primary outcome measure(s)

• 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 — 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 — 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. — 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 — 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

Trial sites (1)

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