Podoconiosis (endemic non-filarial elephantiasis) is a non-infectious disease arising in
barefoot individuals in long-term contact with irritant red clay soil of volcanic origin. The
condition is believed to be caused by the interplay between environmental factors and
genetic susceptibility over a prolonged period of time. In the last decade significant
progress had been made in research on podoconiosis. Acute dermatolymphangioadenitis
(ADLA) is a common and disabling complication of podoconiosis lymphoedema and remain
the most painful and distressing condition, with diverse health, social and economic
ramifications, yet has been very little investigated to date. This PhD thesis is therefore,
aimed at defining ADLA, validating this to measure the impact of ADLA, and to document
the impact of a simple foot hygiene intervention on ADLA and quality of life among
podoconiosis patients.
The study utilized several steps. A Rapid Ethical Assessment (REA) was conducted at the
outset to understand how best to approach the community for consent and develop
context-relevant information sheet and consent format. A case definition of ADLA was
adapted from that used for Lymphatic Filariasis (LF) based on discussion with
podoconiosis experts and trial methodologists. This was followed by developing and
testing a simple, patient-held ADLA diary. Acceptability, feasibility and accuracy of
completion were checked.
Subsequently, the incidence, duration and social impact of ADLA were measured. A total of
1339 patients were recruited, screened and mapped from 18 kebeles (smallest
administrative unit) from Aneded woreda (district) in East Gojjam Zone, Amhara Regional
State, from December 2014 to June 2015. Using randomized controlled design 321 and 329
patients were randomized to immediate and delayed treatment groups, respectively, were
followed for a period of 12 months, from 2015-2016. Comparison of a simple foot hygiene
intervention on ADLA and quality of life were made. Finally, a process assessment using
qualitative techniques, Focus Group Discussions (FGDs) and In-depth Interviews (IDIs)
were conducted to explore stakeholders’ perceptions of the treatment and its key elements
for feasibility and impact. The REA guided the development of information sheet and consent forms. The diary was
found to be acceptable and feasible to be completed by patients and was used in the main
study. Almost all patients (immediate 341 (98%), delayed 341 (99%)) had ever
experienced ADLA. The median (Inter quartile range) experiences of ADLA in the past 30
days at baseline were 2 (IQR 2-3) and 3 (IQR 2-3) with an average duration (in days) of 3
(IQR, 3-5) in the intervention and control groups, respectively.
No significant difference was found on the Incidence Rate Ratio (IRR) of number of ADLA in
the past 30 days and sex (IRR=1.00, p=0.983, 95%CI=-0.90, 1.10), school attendance
(IRR=0.96, p=0.53, 95%CI=-0.85, 1.08) at baseline. However, the number of ADLA episodes
in the past 30 days were 13% higher among those aged 50 and over (IRR=-1.13, p=0.01,
95%CI=1.05, 1.25). Similarly, those with disease stage 3 and above had 39% and 37%
higher rate of ADLA compared to those with stage 2 (p=0.02) and (p=0.03), for the left and
right feet, respectively. Absence of inter-digital lesions was associated with significantly
fewer episodes at baseline (p=0.04). Similarly, presence of wounds in both feet was
associated with a higher rate of ADLA (p=0.001). Further, patients who washed their feet
more than seven times per week had reduced number of episodes in the previous 30 days
(p=0.002).
On the other hand, severity of the most recent episode, absence of swollen lymph nodes
and wounds on the feet were associated with longer duration of symptoms of ADLA
(p=0.001). Poisson regression of Dermatology Quality Life Index (DLQI) scores with feet
washing practices and intensity of the most recent ADLA indicated that the more severely
the most recent ADLA was rated by patients, the higher the DLQI scores were compared to
than those reporting mild attacks (Log OR=0.13, p=0.001, 95% CI=0.05, 0.21). Those who
washed more than once scored significantly lower compared to patients who washed their
feet once per day (Logs OR=-0.25, SE=0.04, p=0.001, 95%CI=0.30, -0.20).
There were a total of 16,550 episodes of ADLA reported in the twelve months of
observation, within 765.2 person years. The intervention group recorded 7,515 and
delayed group 9,035 episodes within 387.1and 378.1 person years; incidence rates of 19.4
(95% CI 18.9, 19.9) and 23.9 (95% CI 23.4-24.4) episodes per person years respectively (IRR) 0.81 (95% CI 0.69, 0.96, p<0.001). At 12 months follow up, patients who received the
foot care and hygiene intervention had 1614 episodes and the delayed treatment group,
1935 episodes providing incidence rates of 18.5 (95% CI 17.6, 19.4) and 24.5 (95% CI 23.4,
25.6) for the two groups respectively (IRR= 0.76, 95% CI 0.62, 0.93) (p<0.001). Similarly,
the total annual duration of symptoms of ADLA for the treatment group (95% CI) was 79
days (95% CI 78, 80), significantly lower than that of the control group at 107 days (95% CI
106, 108) (P<0.001).
At 12 months, there was a significant difference in percentages of presence of mossy
lesions in both legs between the two groups in favour of the immediate treatment group
(32%) and (42%) control group (p= 0.008). Similarly, at twelve months follow up, DLQI
scores were 11 (5-16) and 14 (11-19) for the treatment and control groups, a decrease by
10 and 7 points, respectively (p<0.001).
Finally, the process assessment which explored patients’ perceptions of the intervention
and its components showed that the foot care and hygiene intervention was acceptable to
patients their families and service providers, simple and easy to conduct at home and
thought to bring about health, social and economic improvements in patients’ lives.
The thesis had clarified the clinical expression of ADLA in podoconiosis lymphoedema as
well as documented the incidence, duration and social impact of ADLA. Based on a practical
approach to the preparation and conduct of a RCT, it has made a significant scientific and
policy contribution to scale up treatment as a disease recognition and management tool in
settings where both LF and podoconiosis lymphoedema exist.
The REA proved to be handy and practical in identifying approaches to communities with
little experience in research such as in rural Gojjam in the context of preparing and
launching a RCT among podoconiosis patients. The local term “michader” used to describe
the symptoms of ADLA was understandable to patients in rural Gojjam. It would seem
practical to be put to use in future intervention programs, for example, as a tool to monitor
improvement in the incidence and duration of ADLA once treatment had been initiated. The fact that absence of inter-digital lesions and wounds were associated with lower
numbers of ADLA episodes in the past 30 days at baseline and that the foot care and
hygiene intervention had significantly lowered the incidence and duration ADLA as well as
DLQI scores compared to the controls (p<0.001), indicated the effectiveness of the hygiene
intervention among podoconiosis patients. It also suggests the importance of educating
patients in order to prevent, identify and promptly treat wounds and inter-digital lesions in
the feet in order prevent recurrent episodes of ADLA. Accordingly, NGOs providing
podoconiosis prevention and treatment services should be encouraged to adopt the
treatment package as a safe, affordable and uniform package. However, from the process
assessment it also appears that patients prefer treatment near where they live. Health
Centres (HCs) seem to be far from remote villages and difficult to walk particularly for the
elderly and visually impaired. On the other hand, consideration that the Health Extension
Workers (HEWs) are already overburdened with many packages appears to make the
Health Post (HP) as a less preferable option.
Thus, the full spectrum of the feasibility of these options vis-à-vis other formats of
integration need to be assessed carefully for several reasons including compliance with
treatment. Future treatment provision in other contexts should give due attention to
availability of and unrestricted access to water, local availability and affordability of
treatment products and the all too important gender differences in designing footwear as
participants of the study indicated.
| Date of Award | Jul 2017 |
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| Original language | English |
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| Awarding Institution | |
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| Supervisor | Gail Davey (Supervisor) |
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